BACKGROUND
This study aimed to identify the challenges encountered by both the Drug Administration of Vietnam (DAV) and local pharmaceutical companies in the registration of biological drugs In Vietnam, medicine registration involves an official authorization process by the DAV, allowing products to be marketed or distributed after thorough evaluation for safety, efficacy, and quality The evaluation's primary objective is to ensure that medicines are properly formulated, manufactured, and tested, meeting the necessary safety, efficacy, and quality standards before entering the market.
A drug product registration dossier is a comprehensive collection of documents that includes essential data on the administrative, pharmaceutical, clinical, and labeling aspects of a medication The administrative section provides foundational information about the medicine, its applicant, and the manufacturer The quality section details the active pharmaceutical ingredients (APIs) and the finished pharmaceutical product, while the clinical section ensures the safety and efficacy of the medicine by presenting relevant data.
Quality is a critical success factor in the global market for all businesses, defined as the totality of features and characteristics of products or services In the pharmaceutical industry, Quality Management Systems (QMS) operate within a dynamic environment marked by acquisitions, operational changes, and regulatory compliance challenges The primary challenge for pharmaceutical organizations today is to develop a QMS that emphasizes sustainability and addresses quality issues through organized thinking, transparency, and continuous evaluation Recognizing the role of customers in defining requirements is essential, as monitoring customer satisfaction helps validate that these needs are met A robust QMS not only ensures regulatory compliance and readiness for inspections but also enhances organizational benefits by improving quality, increasing yields, and reducing costs associated with quality failures and import alerts.
And as an effect, in drug registration process, the quality of registration dossier is key factor for a successful registration
In Vietnam, the quality of registration dossiers and the implementation of a quality management system are crucial for applicants and manufacturers to ensure product quality post-registration Quality management involves identifying and managing activities to meet the organization's quality objectives, ultimately aimed at enhancing competitiveness through improved quality performance.
To continuously enhance quality performance, HL Pharma must effectively maintain its quality system while fostering self-motivation and development for improved internal and external quality services Adhering to the GDP/GSP guidelines issued by DAV, the company must also ensure compliance with the quality requirements set for its registered products in Vietnam.
PHARMACEUTICAL MANAGEMENT SYSTEM
Effective management of medicine supply involves four key functions: selection, procurement, distribution, and use To ensure these functions operate efficiently, strong management support is essential This entire process is underpinned by a policy and legal framework that reinforces the public commitment to the supply of essential medicines (MSH and WHO, 1997).
Source: Managing Drug Supply, 2nd Edition of 1997
HL PHARMA
HL Pharma is a diversified local healthcare company that specializes in imported medical devices, pharmaceuticals They also have imported food supplements and tent to reach to cosmetic portfolio
HL Pharma specializes in marketing and trading pharmaceutical products in Vietnam, primarily serving as a distributor for medical devices and food supplements All importation activities are managed by a local government company, which also handles the registration of medical devices and import licenses for food supplements In addition to distribution, HL Pharma is responsible for the registration of pharmaceutical products, storage in warehouses, and managing tender listings for sales to hospitals and pharmacies in the Vietnamese market.
HL Pharma’ business segments are differentiated into 3 categories:
The pharmaceutical sector, particularly biological products, includes recombinant and plasma-based proteins designed to treat hemophilia and various bleeding disorders, as well as plasma therapies for immune deficiencies This segment accounted for 68.4% of total revenues.
The food supplements segment, which includes nutrition products, infusion pumps, inhalation anesthetics, and pharmacy compounding services, accounted for 22.7% of total revenues, highlighting its significant contribution to the market.
Since early 2015, the medical devices segment, which includes treatments for sore throat and asthma, has contributed approximately 8.1% to total revenues, along with registration services for foreign partners.
The company implements a straightforward quality system aligned with the standards of its foreign partners and DAV GDP regulations Given the varying quality management needs for different products, they adhere to multiple quality requirements set by each manufacturer Additionally, they comply with essential processes mandated by local Good Distribution Practices, which will be further analyzed and improved in this final report.
HISTORY OF REGISTRATION IN VIETNAM
In Vietnam, drug registration is also known as marketing approval, marketing authorization or product licensing
Over the past twenty years, medicinal regulation has become increasingly organized on both international and regional levels, exemplified by initiatives like the International Conference on Harmonization (ICH) and the efforts of European and ASEAN agencies Since 1998, the ICH has facilitated the harmonization of approximately fourteen guidelines across the European Union, Japan, and the USA.
In 2003, the implementation of the Common Technical Document (CTD) marked a significant advancement in the application of medicines across three regions (ICH, 2008) Today, numerous regulatory authorities for medicines align their dossier requirements with the guidelines established by the World Health Organization (WHO).
13 which are very close to the CTD format in respect to their national settings as part of the ASEAN harmonization initiative
In 1990, the Drug Administration of Vietnam (DAV) initiated a drug registration process, marking the first time that imported medications were subjected to regulatory scrutiny This essential measure aims to guarantee that only pharmaceuticals demonstrating proven quality, safety, and efficacy are approved for import into Vietnam.
The registration of drugs in Vietnam is governed by the Pharmaceutical Law of 2005, which stipulates that medicinal products must be in the public interest, safe, effective, and of acceptable quality Additionally, manufacturing premises and operations must adhere to current Good Manufacturing Practices (GMP) or other specified regulations The registration guidelines outline specific requirements for various product categories, including chemical medicines, biological products, herbal medicines, food supplements, and medical devices.
In 2009, Vietnam became the second country in the ASEAN region to partially adopt the ASEAN Common Technical Dossier (ACTD) for drug registration, which included specific requirements for EU countries By early 2015, the Drug Administration of Vietnam (DAV) updated its regulations to exclusively utilize the ACTD template and mandated that registration companies adhere to ASEAN stability conditions The 2015 Drug Registration Guidelines also introduced several variation approvals required before implementation, significantly increasing the number of registration dossiers necessary for maintaining product licenses.
DAV has enhanced its expertise in medicine evaluation, leading to revised registration requirements that often result in non-conformance, rejection, or queries for submitted dossiers Consequently, the registration timeline has extended to 14-18 months for chemical products and 18-24 months for biological products, despite guidelines stating that drug licenses should be granted within six months of a qualified submission This delay has increased customer complaints and contributed to the unavailability of medicines in the supply chain.
GENERAL DESCRIPTION OF REGISTRATION PROCESSES
Drug regulation process
A drug registration process generally covers the following areas:
• Pre-marketing assessment and evaluation of the quality, safety and efficacy of a medicine, including compliance of manufacturing sites and processes with Good Manufacturing Practice (GMP) standards
• Assessment and inspection of all components of the pharmaceutical supply chain
• Maintenance of a register of available products, and post-marketing surveillance activities, including random sampling of registered medicines for quality control and pharmacovigilance
• Promotion, advertising and provision of medicines information
All of these activities require an appropriate legislative framework The precise nature and scope of legislation, as well as models for drug regulatory frameworks, varies from setting to setting.
Key players and tasks in drug registration
Drug regulation involves a complex interaction between legal frameworks and scientific principles, as well as collaboration among regulators, pharmaceutical manufacturers, patients, and healthcare professionals In Vietnam, the Drug Regulatory Authority (DAV) works closely with various health sector authorities, including the Ministry of Health and other health protection agencies, to ensure effective drug oversight and public health safety.
DAV must engage with politicians to highlight the necessity of robust drug regulation, ensuring it is adequately funded Effective drug regulation relies on sound legislation and administration, alongside a market control mechanism and enforcement of penalties applicable to both public and private sectors.
Regulatory affairs department
Regulatory Affairs (RA) professionals are essential at the organizational level, guiding healthcare products from conception to obsolescence They offer strategic, tactical, and operational support to navigate regulations, ensuring the efficient development and distribution of safe and effective healthcare products globally The Regulatory Affairs departments within pharmaceutical companies are responsible for ensuring compliance with all relevant regulations and laws governing their operations.
The Regulatory Affairs department plays a crucial role within pharmaceutical companies, acting as a vital link between drug development, manufacturing, marketing, and clinical research It serves as the primary interface between the organization and regulatory authorities, ensuring compliance and facilitating communication (Bevan, 2009).
Regulatory Affairs department contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing
In the late stage of product development, regulatory professionals play a crucial role in submitting the registration dossier, providing a strategic regulatory framework, and advising on procedures and formats They are responsible for collecting, evaluating, and compiling scientific data, managing communication and negotiations with authorities, and maintaining marketing authorizations Additionally, they oversee labeling compliance, manage DAV listings and registrations, and serve as the official DAV correspondent, ensuring effective life-cycle management of the product.
Drug registration process in HL Pharma
In both GDP / GSP guidelines, DAV has not identified any requirement on registration process
In Vietnam, drug registration regulations lack specific requirements for a dedicated Regulatory department or a defined registration process Current practices encompass various sub-processes that ensure compliance with product specifications, quality control, and information accuracy Consequently, HL Pharma operates a streamlined registration process integrated within its R&D framework The primary focus of their regulatory activities is to secure timely product licenses to maintain drug supply continuity, with only one Pharmacist serving as the R&D Head overseeing all registration management tasks However, these activities are not clearly documented or reviewed for potential risks associated with new drug registration regulations.
The regulatory landscape for HL Pharma is evolving rapidly, driven by escalating regulatory obligations, new DAV requirements, and the globalization of the pharmaceutical market As a result, the responsibilities of regulatory departments are becoming increasingly essential and complex.
Starting January 1, 2015, DAV mandated the use of the ACTD dossier format for new drug registrations and renewals, with the latter effective from January 1, 2016 Consequently, all key biological products from HL Pharma will require renewal submissions in 2017-2018 To comply with these regulatory changes, HL Pharma must prepare for country-specific requirements and collaborate with manufacturers to ensure a continuous supply of their medicines.
Since January 2015, the local Health Authority in the ASEAN region has implemented strict requirements for marketing authorization applications, mandating that they include results from stability studies to ensure proper storage conditions.
When navigating the registration evaluation process, it is crucial for manufacturers to understand the differing storage conditions required by ASEAN and EMEA, as these can significantly impact market access Specifically, while EU manufacturers typically store products at temperatures below 25°C, ASEAN regulations permit storage at up to 30°C The Drug Administration of Vietnam (DAV) now mandates a solid justification for any deviations from these conditions during the registration evaluation; failure to provide this justification in writing at the time of submission will result in the rejection of the dossier To mitigate risks of withdrawal or pending approvals for products in the Vietnamese market, manufacturers must implement a robust storage and delivery system that aligns with their stated conditions, thereby ensuring compliance with Good Distribution Practice (GDP) standards and maintaining the quality of their products.
REGULATORY FRAMEWORK
Legislative in harmonization trends
In the 1980s, the European Community (EC) began harmonizing regulatory requirements to foster the development of a unified pharmaceutical market, while also engaging in discussions with Japan and other regions.
US on possibilities for harmonization ICH is a unique undertaking that brings together the drug regulatory authorities and the pharmaceutical industry of Europe, Japan and the United States (K.Sparrow, 2000)
The International Council for Harmonisation (ICH) offers a range of guidelines divided into four categories: Quality, Safety, Efficacy, and Multidisciplinary These guidelines prioritize patient populations and allow for large-scale human clinical trials to commence for up to one year without completed carcinogenicity studies in rodents ICH's primary objective is to enhance the harmonization of technical guidelines for registering new active substances and biotechnological products among its members, thereby improving global drug development efficiency, minimizing redundant studies, and strengthening pharmacovigilance and quality assurance efforts.
The ICH has successfully completed a significant phase, implementing key guidelines related to Efficacy, Quality, and Safety across its three regions To keep these guidelines aligned with the latest scientific advancements, a maintenance procedure has been established, which is crucial for the organization's future and ongoing harmonization efforts Ambitious new guidelines are in progress, including Good Manufacturing Practice (GMP) for Active Pharmaceutical Ingredients (APIs) and Pharmacopoeias Harmonization Additionally, the Common Technical Document and its electronic version will be launched within two years, dramatically altering regulatory dossier submission processes Recognizing the need for broader access to information, the ICH has formed the Global Cooperation Group to share insights on the ICH process and guidelines with non-ICH regions, serving as a valuable resource for understanding and accepting these standards.
Drug Registration harmonization provide benefit for better health:
• Regulatory harmonization offers many benefits to both regulatory authorities and the pharmaceutical industry, and has a positive impact for the protection of public health
The development of harmonized guidelines aims to streamline the regulatory assessment process for new drug applications, ultimately reducing development times and resource requirements This initiative seeks to prevent the duplication of clinical trials in humans and minimize the use of animal testing, all while ensuring that safety and effectiveness are not compromised.
• To harmonize requirements in the drug registration process promotes quicker access to medicines for patients
ASEAN member countries have long established a framework for economic cooperation, culminating in the agreement to form the ASEAN Economic Community (AEC) by 2020, as decided during the 9th ASEAN Summit on October 7, 2004 The AEC aims to create a single market and production base, enhancing the liberalization and movement of goods, services, investments, and funds Given that pharmaceutical products are a crucial part of the healthcare sector, it is essential to expedite harmonization through specific measures and timelines Consequently, a roadmap for healthcare integration has been developed to address these needs.
1 Study the feasibility of ASEAN Mutual Recognition Arrangement (MRA) in Pharmaceuticals by 30 th September 2005
2 Establish alert systems for under-standard and unsafe products by 31 st December 2005
3 Establish labeling standards by 31 st December 2006
4 Implement ASEAN Common Technical Dossier (ACTD) by 31 st December
5 Promote medicinal drugs approval process by apply ASEAN-X principles after full implementation of ACTD after 31 st December 2008
6 Study the feasibility of Harmonization Placement System in Pharmaceuticals into ASEAN market after 31 st December 2009
7 Study the feasibility of Flexible Twinning System in mutual regulatory capacity and resource development
ASEAN leaders have committed to advancing cooperation programs with set timelines aimed at establishing a single market, which will enhance our negotiation power with other regions Consequently, local businesses must adapt to these changes, while government officials should bolster their knowledge and skills to effectively support ASEAN agreements Furthermore, collaboration between public and private sectors is essential for the collective benefit of our nation and its citizens.
The ASEAN Pharmaceutical Harmonization initiative has significantly impacted the drug registration system by promoting and supporting regional trade and cooperation Its primary objectives are to enhance the drug registration process and eliminate technical barriers to trade among ASEAN member countries.
Vietnam Ministry of Health, by DAV, had decided to fully implement ACTD by 31 st
In December 2016, in alignment with ASEAN objectives and government strategies, significant changes were made to enhance regional involvement This article summarizes the key changes and implementation phases related to the adoption of ACTD harmonization in drug registration guidelines, covering the period from 2009 to 2015.
Table 1: ACTD harmonization in drug registration guidelines from 2009-2015
Excessive technical regulations can create barriers to trade; therefore, DAV aims to adopt international standards and align with WTO/TBT obligations when implementing these regulations To enhance consistency and transparency, DAV will provide a Regulatory Practice Guide for regulators and applicants, facilitating the development of efficient regulatory arrangements that ultimately reduce trade barriers.
As a result of this harmonization approach, the involvement of local business sectors, especially small pharmaceutical companies would take into consideration A significant
Administrative documents Drug product specification
Administrative documents Drug substance and drug product section
Dossier format: either ICH CTD or ACTD format
Administrative documents Quality and Clinical/Non- clinical section
Dossier format: ACTD format only
Scope Both renewal and new registration
From 1.1.2010 for new registration, and 1.1.2012 for renewal registration Applicable for chemical medicines only
ICH CTD is acceptable only in case of new drug substance entity
Fully required to follow without justification
Country specific requirements where applicable This enhance chance to accept evaluation per quality risk management based Applicants are required to provide strong rational/justification
To effectively address regulatory changes, it is crucial for national and regional levels to implement 20 essential steps Small and medium-sized enterprises must engage proactively before regulations begin to affect them Pharmaceutical companies should thoroughly assess the potential impacts of these regulations and may consider outsourcing this evaluation as a temporary solution Additionally, there is an urgent need to redesign the registration management processes at HL Pharma to ensure compliance and efficiency.
METHODS AND MATERIALS
Study Design
A descriptive cross sectional study design was used to collect data: Structured questionnaires
Study participants were interviewed through questionnaires in order to get the information required to achieve study objectives
GDP compliance will be evaluated by using checklist and recorded during warehouse visiting Historical audit results by DAV are also be reviewed and compared if applicable.
Study participants
The study engaged drug registration evaluators from the Drug Registration Department (DAV), alongside representatives from local manufacturers and pharmacists, who collaborated willingly Additionally, the Director of the Drug Registration Department participated in the research Participants were interviewed using questionnaires to gather essential information aimed at fulfilling the study's objectives.
Drug registration evaluators within DAV (25)
RA representatives of foreigner manufacturers (25): All of their imported products are biological products
And 45 pharmacists in-charge related to R&D including registration activities in above local representatives.
Study Period
The study took about five months for its completion
The study period includes proposal development in September 2015, data collection in September to Dec 2015 and final report submission in Apr 2016.
Sampling technique
A convenient sampling technique was employed to determine the sample size, given the limited number of evaluators and pharmacies participating in medicine registration within the country Only those study participants who were both willing and available at the survey sites were included in the research.
3.4.1 For identification the challenges of medicines registration process in Vietnam
A convenient sampling method was employed to determine the sample size, given the limited number of evaluators and pharmacies engaged in biological medicine registration in the country Participants who were willing and available at the study sites during the survey were included, and retrospective data on all applications received over the past two years was gathered.
3.4.2 To determine the need of good registration process in HL Pharma
A comprehensive analysis was conducted on retrospective data from all applications submitted between 2009 and 2014, coinciding with the review of current drug registration guidelines in 2009 and their subsequent update in January 2015.
Factors that hinder smooth registration process were evaluated based on the number of dossiers registered, queried or rejected.
Data Collection
- Questionnaires were distributed and the information was required to set the date for collection
The survey collected demographic data, training backgrounds, work experience, and knowledge related to medicines registration It aimed to understand participants' views on challenges and their experiences with regulatory requirements Additionally, the survey included classifications for registration document templates and types of storage conditions.
- Face-to-face interview with responsible pharmacists in HL Pharma during warehouse visiting
RESULTS
Companies represented, and their number of biological products registered
Table 4: Local companies distribution in relation to companies represented, and dossiers applications registered (n%)
Eighty percent of local biological companies represent five or fewer foreign manufacturers, with 56% of these companies acting as representatives for Chinese and Indian firms In contrast, only 12% of pharmacies represent European and U.S companies that provide the ICH dossier format, with HL Pharma being the sole representative for European companies from Germany and Belgium.
Among 25 local companies, 48% registered 11-20 biological products, 36% registered fewer than 10, and 16% registered 21-30 products, with none exceeding 30 registrations This trend highlights the stringent quality management standards required for the registration and distribution of biological products in the pharmaceutical industry.
4.2.2 Time taken for dossier registration approval
None (0) of representatives of the manufacturers agreed with the current time taken of 20-
According to the 2009 Guideline, the approval process for registering a new biological product should take 24 months, while renewal is expected to take 14-16 months However, a survey revealed that 54% of respondents disagreed with the time required for dossier registration, and 48% strongly disagreed, highlighting that the actual registration duration significantly exceeds the guideline's stipulated 6-month timeframe.
During interviews, representatives emphasized the need for shorter evaluation times and interim solutions for invalid license validity during the evaluation of existing products With the implementation of the 2015 Guidelines, which mandate the full ACTD format for technical sections of Biologicals starting January 1, 2017, there are concerns about potential delays in license approvals Biological drugs, derived from living cells, are sensitive to storage and handling conditions, necessitating specialized manufacturing facilities and equipment to ensure quality under aseptic conditions Manufacturers must also manage distribution and storage under controlled conditions to maintain product integrity Strategic safety stock levels are established based on factors like raw material availability and historical supply disruptions, and managing these stock levels is crucial to mitigate risks in the supply chain However, for manufacturers awaiting license approval in importing countries, holding safety stock can be resource-intensive and costly, highlighting the challenges in ensuring uninterrupted supply.
4.2.3 Time taken for dossier registration preparation
None of the manufacturers' representatives recorded the data prior to responding to the questionnaire, highlighting the challenge of obtaining accurate information This issue is further complicated by various factors, including the availability of registration data and the level of readiness in comparison to Vietnam.
25 requirements, as well as the priority and workload based on each organization’ regulatory strategy
Following the initial response, only two pharmacists from HL Pharma were selected for a follow-up interview This choice was made to align with the second objective of the final report, which aims to enhance registration practices at HL Pharma.
Table 5: Time taken for dossier registration preparation in HL Pharma
New dossier Renewal dossier Dossier preparation time (2009-2015)
Germany manufacturers (non-ICH dossier)
Germany manufacturers (non-ICH dossier)
Assessment of knowledge with regards to medicines registration
Table 6: Proportion of evaluators’ knowledge assessment in relationship to the correct responses
Representative in- charge pharmacists (nE)
Know core activity of DAV
Know information to be submitted
Correctly explained information to be submitted
Know importance of SOP for evaluation
Able to mention when was last SOP evaluation reviewed
Mention four categories of information on dossier for generic medicines
Data for Active Pharmaceutical Ingredient
Data for finished pharmaceutical ingredient
Data for safety and efficacy
Among 21 evaluator pharmacists who indicated to know the importance of medicines evaluation, all (100%) could explain correctly the importance of medicines evaluation “that is to ensure quality, safety and efficacy of medicines in the country” Out of 21evaluators who were questioned, only 18 of them knew the information to be submitted before a dossier can be evaluated, and all of them (85.71%) mentioned correctly the information that are required to be submitted 18 ‟in-charge” evaluators mentioned that they knew the process of medicines registration; only 15 of them could explain correctly the process involved “that is assessment of quality, safety and efficacy of medicinal product dossier and analysis of sample eventually granting of market authorization”
A recent assessment of drug registration dossier requirements revealed that 95.24% of evaluators, out of 21 surveyed, demonstrated a strong understanding of the necessary information for preparing a dossier for generic medicines This indicates a high overall knowledge level among evaluators regarding the medicines registration process However, only 15 respondents identified active pharmaceutical ingredients (API), while 18 mentioned finished pharmaceutical products (FPP).
Out of 20 responses, only 6 highlighted the importance of data on safety and efficacy in the preparation of a dossier for generic medicines, while the majority focused on the completion of the application form in the administrative section This discrepancy may be attributed to recent regulatory changes regarding Active Pharmaceutical Ingredients (API) and Finished Pharmaceutical Products (FPP), as well as the limited number of new chemical or drug substance registrations in Vietnam.
Also, medicine registration evaluators knew well the important of using standard operating procedure (SOP) for evaluation of medicinal product dossier (18 of them)
Out of 45 respondents, more than half of them (55.55%) could correctly described DAV as
The regulation of products like drugs, food, cosmetics, and medical devices is essential for safeguarding public health In a survey of 25 participants familiar with medicine registration, approximately 33.33% accurately defined it as the process of evaluating the quality, safety, and efficacy of medicinal products before granting marketing authorization.
A study revealed that the knowledge of "in-charge" pharmacists in local representatives about the medicines registration process is significantly lacking Out of 45 respondents, only 15 (33.33%) answered questions correctly regarding their knowledge, with over half (55.55%) demonstrating low understanding of the registration process for medicines.
Among 30 respondents who knew the information that are required to be submitted in order for the dossier to be evaluated, only 23 (51.11%) were able to mention such requirements Few respondents (26.67%) who knew the importance of using standard operating procedure (SOP) for evaluation of medicinal product dossier, only 3 were able to mention the year when that SOP was last reviewed in their companies.
Practice among DAV evaluators on medicines registration
Practice among evaluators during medicines registration are summarized in Table 7 below
Table 7: Summary of responses to practice on medicines registration among evaluators
Number of dossiers evaluated since were employed
Dossiers that are insufficiently submitted
Often (1-2 official comments) 12 57.14 Very often (3-4 official comments)
Participant in conducting training on new guidelines in
* working days, and DAV evaluators have to work 6 days per week to conduct evaluation
*** In 2014-2015, DAV has not conducted any training on new Guideline specifying for biological product registration The 2 of 21 respondents were the Head of department who were involved in General
Introduction section for new Guideline before implementation in Jan 2015
A significant number of evaluators identified the insufficient number of evaluators as a key obstacle to timely medicine dossier assessments Additionally, 90.48% of respondents highlighted the lack of regular and specialized training as a factor impacting medicine registration Furthermore, all evaluators (100%) pointed to poor dossier organization and the quality and authenticity of information as major contributors to delays in the registration process Notably, there were no approvals recorded immediately following the first evaluation during the study period Since December 2014, the Directorate of Drug Administration (DAV) has implemented a list of insufficient criteria to classify dossiers for official rejection after the initial evaluation, in line with Good Regulatory Practices aimed at ensuring the quality of registration dossiers The absence of updated reference materials during evaluations also posed challenges.
28 mentioned as one of the challenges in drug registration process (DAV registration process – Annex 2).
ASSESSMENT OF CHALLENGES IN DRUG REGISTRATION
Challenges encountered by evaluators (21)
The challenges faced by evaluators during medicines registration are summarized in table 8 below
Table 8: Challenges encountered by evaluators (n!)
Type of defect No Cumulative %
Lack of regular and expertise training 8 9,87
Lack of updated reference materials 9 11,11
A significant 23.45% of evaluators identified the inadequate number of evaluators as a key barrier to the timely assessment of medicine dossiers Additionally, 9.87% highlighted insufficient evaluation time as a challenge in the registration process The lack of regular and expert training, also noted by 9.87% of evaluators, further impacts the efficiency of medicines registration Other reported issues include poor dossier arrangement and concerns regarding the quality and authenticity of information, which contribute to delays Furthermore, the absence of updated reference materials during evaluations was recognized as a challenge in the medicines registration process.
The analysis using a Pareto chart revealed the primary causes of delays in the registration process, with the length of the bars indicating the percentage of each cause The findings highlight that the major challenges faced by regulators stem from insufficient training, outdated materials, and unclear communication This underscores the applicability of the Pareto principle in identifying key areas for improvement.
Figure 2: Reason of delay in DAV registration process
Following comprehensive interviews with regulators about the perspectives of key informants on the challenges faced in the medicines registration process, four primary themes emerged as the most significant obstacles identified by the interviewees.
(i) Long registration time/meeting timelines
(ii) Communication gap between DAV and customers
(iv) Lack of expertise in some areas
(v) Lack of updated medicines register
This study utilized questionnaires and in-depth interviews to evaluate the knowledge of DAV evaluators and pharmacists involved in medicine registration It uncovered several issues related to the registration process, highlighting the necessity for the medicines regulatory authority to maintain a sufficient number of qualified staff for effective evaluation and registration Furthermore, the findings indicated that while most evaluators had received training in dossier evaluation, there is a pressing need for enhanced technical assistance to improve the overall efficacy of the DAV.
However, no workshops or face-to-face training forum from evaluators specialized in vaccine and biological drug registration to Applicants have been conducted till end of Q1
In 2016, it was highlighted that most staff engaged in medicine evaluation lack the necessary expertise for this critical process According to the World Health Organization (WHO) in 2010, the authorization of medicines for sale in a country must rely on a scientific assessment of their safety, efficacy, and quality, coupled with effective communication of these findings.
Lack of updated reference materials
Lack of regular and expertise training
30 and educate Applicants on evaluation process This is considered the core function of the regulatory authority in an effective registration process.
Challenges encountered by representatives of manufacturer (40)
The challenges faced by representatives of manufacturer are summarized in table 9 below
Table 9: Challenges encountered by representatives of manufacturer (n@)
Number of managing factor No Cumulative %
Majority of representatives of manufacturers complained that registration process takes long time 38 (95.0%),and 31(77.5%) representatives mentioned inadequate number of DAV evaluators was the cause of delay in approval process
Also, the third issue identified as challenge factor in registration process was inefficient registration database 29 (72.5%)
Figure 3 Reason of delay in registration process (encountered by Pharmacist-in-charge)
The findings identify the primary issue causing delays in the registration processes at DAV, highlighting opportunities for applicants to enhance their registration efficiency By addressing this significant problem, potential quality improvement solutions can be developed to streamline the timely registration experience for applicants.
Long registration time Inadequate number of evaluators Inefficient registration database Delay of queries submission Communication gaps
31 in registration process, the Pareto was valuable tool to identify the most common cause of customer dissatisfaction in registration in Vietnam, was long wait times for approval
Key informants highlighted significant challenges in Vietnam's medicines registration process, with manufacturers acknowledging these issues The three primary challenges identified include an inefficient registration database, delays in query submissions, and communication gaps between the Drug Administration of Vietnam (DAV) and customers.
To address the prevalent issues identified as stemming from training and communication deficiencies, a change management strategy for both DAV and Applicants should prioritize enhancing employee training, developing core competencies, and refining registration skills.
6 REVIEW CURRENT QUALITY MANAGEMENT IN HL PHARMA.
GDP system in HL Pharma
Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry, especially for biological products
Good Distribution Practices (GDP), as outlined by DAV guidelines, establish a quality system for warehouses and distribution centers handling medicines The World Health Organization (WHO) emphasizes that pharmaceutical distributors must adhere to internationally accepted GDP regulations to ensure consistent quality management throughout the entire supply chain, from raw material delivery to final drug shipment To meet the new ASEAN-specific storage requirements, implementing a controlled storage and delivery system is essential for manufacturers like HL Pharma to demonstrate their commitment to product quality This highlights the critical need for re-assessing and enhancing GDP/GSP compliance.
An independent assessment of HL Pharma's compliance with international Good Distribution Practice (GDP) requirements is crucial for ensuring that their quality management system aligns with GDP guidance and is prepared for new drug regulations Since obtaining their first GDP certificate from DAV in 2010, HL Pharma has undergone a review process, with the next certification due by September 2016, demonstrating adherence to local quality standards However, a recent warehouse visit revealed deficiencies in their documentation management, which is a critical aspect linked to their registration strategy for adapting to new drug registration regulations.
During the visit, we encountered delays in obtaining retrospective records of events, making it difficult to determine whether non-conformities had occurred and been managed effectively Additionally, there was a lack of reliable evidence to support their quality activities, which is a common challenge faced by small businesses.
HL Pharma, like many smaller companies, may not have extensive documentation like larger corporations, but they can still greatly benefit from organized and easily accessible records To enhance their inefficient registration database, HL Pharma must effectively manage their organizational records to comply with the increasing demands of New Drug registration and to improve business outcomes Although the Drug Registration and GDP guidelines from DAV do not specify document management requirements, they do emphasize the applicant's obligation to provide sufficient and accurate data, reports, and information throughout the drug registration process.
(Article 3 Item b- Requirements, rights and obligations of the applicants) (Drug
In order to enhance the overall quality system and improve registration management, HL Pharma should adopt a systematic approach to record management, ensuring sufficient application and provision of records for competent agencies upon request This strategy will facilitate better organization and maintenance of records, contributing to long-term development.
• make the records they really need
• realise the true value of their records as information assets
• find and access all of the right records at the right time and use them with confidence
• preserve records for as long as required and then dispose of them appropriately
• assess the relative importance of different kinds of records
• identify and protect records containing sensitive, confidential or private information, and
• control costs associated with finding, accessing and preserving records
To enhance the quality system at HL Pharma, a critical short-term action identified from warehouse visits and BSC evaluations is the establishment of a record management process for the distribution storage of biological products This process will serve as essential support for new and renewal registrations in 2017-2018.
Registration system in HL Pharma
6.2.1 The current role of regulatory activities within HL Pharma
A process is defined as the transformation of inputs into outputs, involving a series of activities that utilize organizational resources Process management focuses on the effective management of these processes rather than solely on results, necessitating skilled individuals capable of navigating a complex, process-oriented environment In the case of HL Pharma, the current registration process encompasses all regulatory activities throughout the product lifecycle, from pre-launch to completion.
33 marketing It does not define clear responsibilities, no specific criteria in term of time required while this is key important for business planning
The existing product development process at HL Pharma lacks standardized procedures to effectively address business requirements and implement process improvements as outlined in the new Guideline Survey results indicate insufficient training and communication regarding the current process, along with inadequate resource allocation for Regulatory Affairs (RA) activities Consequently, HL Pharma operates as a highly reactive organization, focusing on addressing immediate issues rather than developing proactive processes to prevent potential challenges.
The complexity of registration processes often leads regulatory professionals to focus on specific components rather than the entire regulatory framework However, it is essential for regulatory and R&D departments to understand how their individual roles integrate into the broader regulatory process, ensuring that all components work together to achieve overarching policy objectives.
So the registration strategy needs to be developed in holistic manner
The study proposes a Regulatory Affairs (RA) strategy for HL Pharma utilizing the Balanced Scorecard (BSC) to address the 2017 registration requirements This strategy aims to enhance the registration framework at HL Pharma effectively, aligning with the company's mission through 2025.
The study focused on enhancing the registration process at HL Pharma to align with good regulatory practices It emphasized effective process management, which involves planning, implementing, controlling, and continually improving the processes to produce a high-quality registration dossier.
Figure 4: The plan–do–check–act cycle
The plan–do–check–act cycle is a four-step model designed for implementing change effectively To address the current registration management issues at HL Pharma, it is essential to establish a process that not only solves these problems but also allows for the review, testing, and incorporation of feedback into our strategy prior to full implementation.
Planning and redesign the process
The planning process should begin with an assessment and overview of the current drug regulatory situation in the company, and an inventory of the market
The regulatory department must ensure that its files include all necessary information as outlined in the new guidelines This data should be accurate and up-to-date, reflecting the current needs of marketed drugs.
The appropriate registration timeline required for each drug registration application
In preparation for the drug registration management in 2017, it is essential to review and update the regulatory registration procedures
To effectively address the challenges and risks faced by HL Pharma, it is essential to thoroughly understand the operating environment Regulation must be tailored to specific risks rather than adopting a uniform approach, as different strategies are necessary for various situations Additionally, as the operating environment and associated risks evolve, regulators must maintain a flexible and continuous assessment capability to adapt to these changes.
A Assessment and overview of the current drug regulatory situation in the company
Table 10: Assessment and overview of the current drug regulatory situation in the company
Assessment Element Relevance and Remarks
Presence of requirements to submit applications for:
If requirements are not in place or are notoriously not complied with, it will delay the implementation of new drug registration in
HL Pharma, resulting in business lost
How many applications are received/expected every year for 2016-
If this information is not readily available or cannot be reliably obtained from existing files, there can be doubts about the reliability of the drug registration system in place
Presence of an efficient inspection system covering manufacturing and distribution channels
The absence of regular inspections of the distribution channels poses a serious challenge to the credibility of the information on marketed drugs available
The lack of documentation management in product distribution and storage requires a new standard procedures
Presence of written procedures and compliance with them
Assessing the potential for utilizing existing information in a CTD dossier is crucial Without assurance that standard procedures have been adhered to, particularly concerning the completeness of information, there is a high likelihood that the available data is either incomplete or inconsistent Consequently, this makes it unsuitable for direct integration into the new requirements.
By the first quarter of each year, the R&D department is required to present a two-year registration plan to prevent supply issues arising from license changes and expirations This timeline is informed by historical data on registration preparation, submissions, and approvals, while also considering tender supply, shipping, and stock schedules to accommodate temporary licenses when necessary It is essential to communicate, review, and document a clear registration plan To facilitate this process, we have developed a record template known as the RA Roadmap, designed to manage registration changes and assess their impacts across various functions.
B Estimate time required to enter registration information into the new requirements
The time required for data preparation varies based on application type and the manufacturer’s country, particularly regarding the availability of the CTD dossier for EU and non-EU products HL Pharma has not previously accounted for these factors in its registration process Additionally, the responsiveness of the Manufacturer RA is crucial, as it can vary depending on their familiarity with Vietnam's specific requirements By assessing these elements, HL Pharma can better understand its situation and incorporate preparation time into the drug registration process This includes considering the registration evaluation timeline from DAV, allowing the company to create a more accurate and measurable launch plan.
To effectively prepare for the new drug registration guidelines, companies must review and update their regulatory procedures A critical aspect of this process is determining the adequate time needed for various processing steps involved in registering new drug products, including those with new chemical entities (NCEs) and generics, as well as for renewing existing licenses, making variations, and obtaining temporary certificates.
The registration process is essential for regulatory departments as it enables tracking of all applications, identifying those pending assessment decisions, and providing real-time status updates To effectively manage various application types, which require distinct assessment procedures and preparation times, preliminary work is necessary This ensures that the required assessment procedures and their respective steps are properly integrated into the registration database and computer system setup.
It is essential to establish clear procedures for archiving and accessing hard copies of documentation after licenses are granted Effective records management will determine the retention period for these documents and outline the proper methods and timing for their destruction.
Last but not least, procedures must clear responsibilities of relevant functions in drug registration preparation
In the realm of Regulatory Affairs (RA), key procedures include registration for promotion, management of tender documents, and record management for distribution and storage, all aimed at aligning with the 2017 regulations that emphasize stability study requirements This study specifically targets enhancements to the product registration procedure.
D Review and Update Forms and Certificates
CONCLUSION AND RECOMMENDATIONS
This study has found that biological drugs registration process in Vietnam is faced with a number of challenges which are multifaceted from evaluators, knowledge management, manufacturers and their representatives
A recent study indicates that drug registration processes exceed the timeframes outlined in the official Circular, primarily due to human factors such as resource limitations, knowledge management issues, and insufficient training Specifically, the Vietnam Health Authority faces challenges due to a lack of evaluators, which stems from its limited capacity to hire adequately This shortfall leads to delays in the evaluation of applications, ultimately prolonging the registration timeline.
Limited knowledge and the absence of an effective registration management system among pharmacists in charge of medicine registration contribute to delays caused by poorly prepared medicine dossiers Early identification of this issue could significantly reduce the number of queries and rejections, ultimately streamlining the registration process.
To maximize limited resources, it is crucial to implement strategies that optimize their use Regulatory authorities can enhance their effectiveness by considering various educational approaches outlined below.
For DAV to enhance vaccine and biological registration process in Vietnam
The DAV registration process emphasizes collaboration with key stakeholders, including specialists and professors from the University of Pharmacy, to review and enhance the undergraduate pharmacy training curriculum by integrating regulatory issues related to medicines registration Additionally, DAV, alongside manufacturers and their representatives, should implement continuing education programs for pharmacists-in-charge to ensure they are equipped with the latest knowledge and technological advancements in medicines registration, ultimately streamlining the registration process.
In various countries, technical advisory groups or committees are formed to offer expert guidance to the Drug Regulatory Authority (DRA) Comprising national specialists in fields such as clinical pharmacology, pharmaceutical sciences, and clinical medicine, these groups or their specific subgroups convene monthly to address particular issues This strategy effectively enhances the registration process at the Drug Approval Venue (DAV) by ensuring consistent technical support.
DAV should foster strong communication with regulatory authorities to enhance collaboration In situations where resources are limited for analyzing extensive technical documentation or conducting comprehensive studies, establishing connections with more advanced regulatory bodies in other countries can be beneficial This collaboration enables Drug Regulatory Authorities (DRAs) to share experiences and build a solid foundation for informed licensing decisions regarding active ingredients.
DAV should enhance communication with local applicants by organizing more training sessions and face-to-face meetings to clarify regulations They need to promote regular activities, including conferences and training courses in various areas of pharmaceutical manufacturing, case studies, and registration guidelines, while also referencing other regulated markets By taking a leading role in advancing knowledge of pharmaceutical technology among companies and connecting with international conferences on medicines, DAV can shorten registration timelines, improve the quality of registration dossiers, and reduce their workload.
Investing in a quality-by-design approach is essential for streamlining the registration process, enhancing the efficiency and reliability of application evaluations When the safety and efficacy of a product are well established, quality becomes the primary focus for licensing authorities By concentrating on well-established drugs, regulatory bodies with limited resources can more effectively assess the manufacturing process, product specifications, regulatory status in other regions, and the Good Manufacturing Practice (GMP) profile of manufacturers.
To ensure long-term development, DAV should implement a regulatory framework that enables the automatic identification of products registered and utilized in countries with strict regulatory standards, thereby facilitating a reduced evaluation timeframe.
39 offers electronic online services that enable companies to monitor the registration status and feedback of their products anytime and anywhere This innovation significantly enhances communication with DAV evaluators and accelerates the process of information requests.
HL Pharma should hire or designate a regulatory affairs staff to streamline the registration process The study highlights that pharmacists in charge of medicine registration often lack the necessary knowledge, leading to delays caused by poorly prepared medicine dossiers To address this issue, it is essential to implement an effective registration strategy and provide training to enhance registration skills, ultimately reducing the number of queries and rejections and expediting the overall registration process.
HL Pharma should utilize ISO 9001:2000 and ISO 14001:2004 Section 4.2.3 as essential guidelines for developing an effective record management system Implementing the requirements of these ISO standards is a significant task that necessitates the involvement and support of the entire organization, particularly the top management and R&D team It is crucial for them to recognize that poor records management can lead to serious risks, including compromised service delivery, ineffective decision-making, and diminished ability to manage and report on quality and business activities.
Establish mechanisms to regularly receive technical support
Ensuring quality of information is a crucial part of maintaining a computerized system
Neglecting regular and thorough data reviews can lead to unreliable reports and statistics, ultimately undermining the credibility of the R&D or RA department To mitigate this risk, it is essential to provide ongoing training on drug registration regulations and foster a close partnership with manufacturers' R&D teams to ensure the timely preparation of common technical dossiers for submission.
Create simplified and meaningful procedures
In order to optimize registration activities in HL Pharma to meet good registration management, the study has followed Process improvement methodology to propose a redefine Drug registration procedures (Annex 6)
To enhance registration management at HL Pharma, it is essential to develop procedures for record management, tender and marketing material registrations, and labeling control as integral components of the regulatory affairs strategy.
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2 Alec Sharp and Patrick McDermott (2008).Workflow Modeling: Tools for Process
3 Drug Administration of Vietnam Circular on registration of drugs (No
4 David Bevan (October 2009) Tips and Traps for Regulators The Queensland Ombudsman
6 ICH harmonised tripartite guideline (2008) Pharmaceutical quality system Q10 Current Step 4 version dated 4 June 2008
7 Malcolm K Sparrow The Regulatory Craft: Controlling Risks, Solving Problems, and Managing Compliance
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Practice and Organisational Performance in Manufacturing Industry: A Conceptual Framework International Journal of Contemporary Business
A CHALLENGES OF MEDICINE REGISTRATION PROCESS
QUESTIONNAIRE: DIRECTOR OF MEDICINES AND MANAGER OF MEDICINES REGISTRATION
No ………… Name of the Interviewer………
1 What is your professional status?
2 For how long have you been working in this institution?
Prove - on the position you are heading - training on medicine registration
3 How many subordinates are working under you?
Prove - on their number of working years at DAV, -their experience -and knowledge on medicines registration
4 What medicines registration process is all about?
- avagage timeline for a submission approved
- Number of supplement(s) per submission
5 What are challenges of medicines registration
- time taken for assessment of dossier
- comprehensibility with regard to registration guidelines
- update of registration guidelines -up date list of registered medicines
6 If you were in a position of highest authority, in your opinion what would be the first action that you would take to improve drug registration process in Vietnam
B CHALLENGES OF DRUG REGISTRATION PROCESS IN VIETNAM
QUESTIONNAIRE: EVALUATOR (Code 01) – PHARMACISTs IN CHARGE
No ………… Name of the Institution/Working place………
Name of the Interviewer……… Date:
2 Your profession: a) Pharmacist b) Medical Doctor c) Others specify
SECTION II: Please tick when necessary the answer of your choice
3 What are your daily activities?
4 How long have been working on the same position? a) 0-0.5 year b) 0.5 – 1 year c) 1-2 years d) 2 -5 years d) Above 5 years
5 How long have you been doing medicines evaluation? a) 0-0.5 year b) 0.5 – 1 year c) 1-2 years d) 2 -5 years e) Above 5 years
6 Have you received any training on drug registration evaluation/assessment? a) Yes b) No
If yes, explain where and for how long? _
7 Do you know what drug registration process is? a) Yes b) No
8 Do you know information that are required to be submitted before dossier can be evaluated? a) Yes b) No
9 Do you know the importance of using standard operating procedure (SOP) during drug registration evaluation? a) Yes b) No
If yes, please explain when it was last reviewed
10 During drug registration evaluation, do you follow the SOP? a) Yes b)No
11 How many medicines evaluation have you done? (in numbers)
12 How long do you normally take to evaluate one dossier? a) Less than One day b)2 days c) 3 days d) More than 3 days
13.How often do you encounter dossiers that are insufficiently submitted resulting in rejection or queries being raised? a) Rarely b) Moderately c)Very often
14 Was the drug registration guideline reviewed/updated recently within last 12 month? a) Yes b) No c) Do not know
If yes, explain if newly updated version comply with the current situation of drug registration criteria of the WHO and other regional harmonisation policy?
15 What are challenges encountered during drug registration process? i) ii) _ iii) iv) _
If working with Drug Regulatory Authority (DAV), then answer question 16 and 17
16 How do you describe the support you get from the management? a) Strongly agree b) Agree c) Undecided d) Disagree e) Strongly disagree
17 How much are you satisfied with your dossier evaluation payment? a) Very dissatisfied b) Dissatisfied c) Undecided d) Satisfied e) Very satisfied
Medical Control Council (MCC) activity
Committee activity and Analytical times based
Vietnam Regulatory Drug Approval Process
Renewal /New generic registration Process approx 14-18 months for approval New registration / Biological registration- Standard process approx 24-28 months for approval†
Applicant submits new drug application and dossier to DAV
DAV screens application and dossier
Clinical Committee reviews application and sends questions to applicant
DAV returns application to applicant with comments
Pharmaceutical and Analytical Committee reviews application and sends questions to applicant
Biologics Committee reviews application and sends questions to applicant
Scheduling Committee reviews application and sends questions to applaicant
Administrative review and send questions to applicant
Applicant submits responses Second review by each committee
Clinical Committee makes approval recommendation to
Pharmaceutical and Analytical Committee makes approval recommendation to
Biologics Committee makes approval recommendation
Scheduling Committee makes approval recommendation to
Naming Committee makes approval recommendation to
DAV approves registration and marketing authorisation granted
Drug added to the Register of Medicines
Sources - DAV website: http/Moh.gov.vn
2 Business support, review and update registration timeline versus launching and supply timeline
3 Enhance the alignment in managing registration data
1 Partnership with manufacturer; stakeholder to develop ASEAN/
2 Active participation in industry association
3 Proactive supporting to ensure RA input for readiness for business plan
1 License compliance review and approval on time
2 Labeling compliance review to ensure no supply gaps
3 Business sustainability and supply continuity
To be an active scientific business partner, maximizing benefits and minimizing risks to the patient and HL
Pharma, while ensuring highest quality ethical standards Regulatory system is able to support HL Pharma become a leader in the local biological industry by 2025
Mission To provide resources and tools to maximize HL Pharma’ competitiveness and enable economic growth in 2016-
2017 Ensure that HL Pharma is compliant with all local regulatory agency and applicable foreign quality requirement
Learning & Growth: to fully comply New Drug registration
1 Have the right culture/org/talent to achieve 2017-2018 goals
2.Improve retention of staff through provision of appropriate training, support and mentoring
1 Re-design Drug registration process
1 Higher level of credibility with regulatory agencies
2 Good working relationship with global/regional stakeholders
3 Establish RA as key partner in
The four perspectives of the Balance scorecard (BSC) in 2016 RA strategy …
Main Driver of Performance Secondary Influence
RA to proactively respond to the regulatory challenges in order to maintain a prosperous & productive 2016-2017 business sustainability and supply continuity
– Continuous completion of License, improving documentation system compliance
– Completion of ongoing registration plan ready for 2017 new requirements
– Close gaps for on-time renewal and ad hoc submissions (variations, temporary license, labeling compliance)
– Develop good documentation and Distribution & storage process (to be used as
Justification supporting for biological registration data)
– Stockpile issues & increase need for RA to do ad hoc submissions during renewal registration review due to long time registration and workload (12-18 months from date of current visa expired)
– Resource gaps for labeling compliance due to new / change in license required for supply continuity
– Inappropriate trainings/ allocated resources for 2017-2018 regulation changes
Robust Individual development plan Execution
Alternative registration plan and temporary license
Maintain 100% existing portfolio (no supply gaps)
Required By KPI Customer Engagement
Identify key stakeholders in Health Authority after New Guidelines effective/ re-organization, map interests and plan of actions to build relationship
Mapping key contact from manufacturers who supports registration preparation
Having at least 1-2 meeting/quarter with key Manufacturer’ members
Establish HL Pharma as key contributor at local Industry Association, a key partner of HA for medical devices
Q2 16 100% attendance at local Industry Association meetings Key contributor at DAV annual meeting
Review and leverage on existing program from Marketing department Identify topics of interest from DAV
100% meetings conducted Execute at least 1-2 influencing meeting with DAV Officers
Required By KPI Business Support
Alternative registration plan and temporary license
Align on all products requiring new/renewal in 2017-2018 with alternative licensing plan
Secure MAF support and finalize registration plan
Logistic manager Head R&D, Marketing managers
All critical products have alternative license registered, where available
Stock-up plan is well discussed in monthly operation review (MOR)
New and renewal registration plan completed in right time manner followed all required requirements Renewal Submission on-time and no rejection
Logistic manager Head R&D, Marketing managers
100% critical registrations submitted on time Bimonthly update on registration status
Alternative solutions to avoid business impact
Temporary import permit where applicable
Proceed labeling change / relabeling solution to reduce stockpile
Quarterly review and update labeling development status
Owner Action/ Milestones Who By KPI
Secure internal support to conduct self inspection in 16-17
Audit preparation plan Review findings and identify corrective actions for improvements
Logistic manager Head R&D Warehouse staffs
No critical findings Less than 3 minor findings for improvements
100% of Product storage record information for marketed product is up-to-date;
Develop local distribution & storage process
TBC 0 Product safety information flagged in GDP audit and escalation report
Standardize and improve on working process with Manufacturer to ensure compliance and timely regulatory submission/approval
Q2 16 Reporting roadmap template and SOP in place by end of Q2
Owner Action/ Milestones Who By KPI
One case study per team member to present and share during lunch-and- learn session
Enable to prepare registration dossier
Robust individual development plan (IDP)
Bi-monthly review of Individual Development Plan with each team member
At least 1 soft-skill training and 1 technical training organised for
TBC 100% Employee’ satisfaction on their IDP
Owner Action/ Milestones Who By KPI
Goal: Building quality into regulatory dossiers and the preparation process : ‘by Knowing and meeting core requirements
No rejection for all submissions All variations are passed (in less than 6-9 months)
Renewal submissions: (in less than 16 months)
100% on time submissions 95% on time approval for minor and major variations
90% on time approval for new/renewal submission
Training program for RA on Drug regulation (Vietnam and ASEAN)
Participate in at least 1 technical training organized by Vietnam Health Authority
100% training completed Within RA budget
Owner Action/ Milestones Who By KPI
Improve quality of registration (con’t)
Goal: Building quality into regulatory dossiers and the preparation process : ‘by Knowing and meeting core requirements
Standardize CTD with country specific requirements
Identify key influencing meetings and arrange learning exchange meeting to other ASEAN country
Identify key gaps to address and arrange learning/ education meeting with MAF RA
Common template ready by Q1 16 and reviewed and approved by ASEAN Head R&D and Vietnam Health Regulators by Q2 16
At least 1 meeting per Quarter to share best practice
Owner Action/ Milestones Who By KPI
Improve quality of registration (con’t)
Goal: Building quality into regulatory dossiers and the preparation process : by Knowing and meeting Internal expectations’
Standardize registration timeline per type of applications
Identify relevant functions and resources required for drug registration
Identify competencies and skills needed to meet DAV requirements and ASEAN Harmonization countries
Common template ready by Q2 16 and reviewed and approved by ASEAN country RA, Vietnam Health Regulators by Q2 16
At least 1 meeting per Quarter to share best practice
Calculate how many applications for 2016-
Recalculate numbers of applications on the basis of recent changes in requirements
- Case of re-Dossier formatting
- Case of justification for storage condition
- Case of Temporary licenses for 2016-2017 renewal registrations
Calculate registration time required on the basis of average figures:
Type of registrations (to have sufficient supporting documents for initial submission)
- New registrations: 6 months to have all supporting documents
Type of dossier format (done by HL Pharma)
Registration preparation average time needed:
- Temporary licenses: 2 months Type of dossier format: to be initiated in 3-4 months before average timeframe for Non-EU product registration ANNEX 4
Dashboard of Key Product Filings in VIETNAM
(E: Jan 2016) Checking RA requirements Receipt of Dossier
Receipt of Dossier (Estimated Date) (Actual Date)
Submission (Estimated Date) (Actual Date)
First query from Health Authority
Submission ( timeline to be inserted ))
Risks/Issues Level (L/M/H) Mitigation Plans/Actions Supported / By
(product code, First of code)
Man hours for the filing: hr
This document describes the HL Pharma Quality Management System (QMS) procedure for developing, designing, and implementing registration applications, and maintaining traceability of registration data, throughout the product lifecycle
This document is relevant to all entities, functions, and personnel involved in product registration, labeling, and relabeling processes throughout the product lifecycle Key areas of focus include Manufacturing/Operations, Marketing, Manufacturer Quality & Regulatory Affairs, Research and Development, Logistics Management, Tender Project Management, and Labeling Design & Development.
In Scope Out of Scope