New Drug Registration Process in Vietnam (DAV)

The regulation of drugs in Vietnam is the responsibility of the Drug Administration of Vietnam (DAV). The DAV is a unit under the Ministry of Health of Vietnam. Any drug must be permitted by the DAV to be marketed in the Vietnamese market. As a part of amending its pharmaceutical sector to provide the public with improved health with safe & quality medicines, recognition was given to its delayed registration process of drugs. So, a new registration process was introduced.

Continue to read more about the new registration process for drugs, steps involved, the main changes that happened and more.

New Drug Registration Process in Vietnam

The new drug registration process in Vietnam was introduced by DAV (Drug Administration Vietnam) in October 2022 with the issuance of Circular 08/2022/TT-BYT by the Ministry of Health. The new process aims to streamline the registration process and make it more efficient.

The main changes under the new process include:

A simplified application dossier format
A shorter review period
A new online registration system

The simplified application dossier format includes a number of new documents that are not required under the previous process. These documents include:

A Certificate of Pharmaceutical Product (CPP) issued by the EMA or any SRA (Stringent Regulatory Authority)
Legal documents of the manufacturer of APIs, excipients, capsule shells, semi-finished herbal medicine products, and herbal ingredients to prove compliance with GMP requirements

The shorter review period under the new process is within a maximum of 12-month period for domestic drugs and 90 - 110 days for imported drugs. This is a significant reduction from the previous review period. The time taken to evaluate new and generic drug approval in Vietnam is shorter when compared to developed countries.

The new online registration system allows applicants to submit their applications and track the progress of their applications online. This is a more convenient and efficient way to register drugs in Vietnam.

Process of Product Registration, Vietnam

The new drug registration process in Vietnam is a welcome change that will make it easier and faster for companies to register their drugs in the country. The new process is also more transparent and efficient, which will benefit both companies and patients.

Here are the steps involved in the new drug registration process in Vietnam:

Review your product details and understand the regulatory requirements applicable to your product.
The regulatory requirements can vary according to the type of product. For example, the application dossier prepared must be in compliance with the ICH CTD or ASEAN format. For one product preclinical and clinical documents might be needed while for the other it might not be necessary. So, it is important to understand the requirements set to comply for each product like the generic drug, new drug, imported drug…
Compile and submit the application dossier. The application dossier must contain administrative documents, quality documents, preclinical and clinical documents. However, for generic drugs the first 2 are only required to be submitted. The list of documents to be submitted for the circulation registration certificate for generic drugs is given below in this article.
Evaluate the application dossier. After the receival of a registration dossier that is complete, it is reviewed by the Drug Administration of Vietnam and is sent for evaluation to the expert evaluators. The evaluators then evaluate and send their opinion to the Drug Administration of Vietnam within the designated time.
Respond to queries and receive the product registration certificate. If the Drug Administration of Vietnam sees that the application dossier is lacking in terms of the requirements, then they state the reasons accordingly and will be provided as a written response. Supplementary documents can be requested by DAV from the applicant or DAV can clarify the issues concerning the application dossier. A marketing registration certificate of the drug will be issued after reviewing the supplementary documents or the explanation given.

Documents to be Submitted

The application dossier must include the following documents:

1. Administrative Documents

Registration application as per Form 5/TT
Include the Power of Attorney in the name of registration facility, if any
Authorization letter
Samples of drug labels, medicinal ingredients as well as the instructions for use for drugs expected to be circulated
For Vietnamese registered establishments, Certificate of eligibility for pharmaceutical business.
For foreign registered establishments, all legal documents and license to establish representative office in Vietnam
Legal documents for manufacturing facility of pharmaceutical excipients, ingredients, capsule shells, semi-finished pharmaceutical products and medicinal materials.
Certificate of testing facility (when applicable)
Samples of drug labels and instructions for use of the drugs that are actually circulated in the manufacturing country or country granting Certificate of Pharmaceutical Products (CPP) for foreign drug registration dossiers.
Cover page
CPP
Certificate of medicinal ingredients permitted to be produced or circulated in the manufacturing country for registration dossiers of abroad produced medicinal ingredients.

2. Quality Documents

Description and ingredients as per the instructions given in Part P. 1 - ACTD
Quality standards and testing methods for finished drugs
Production of the finished products which must also include the production batch formula, manufacturing processes and process control, control of intermediate products and critical steps.
Testing certificate of the finished product
Reports on stability research of the finished drug
Describe the materials, form and quality standards for primary packaging

The application dossier must be submitted in Vietnamese or English. Particularly the instruction of drug use and the product characteristics summary must be written in Vietnamese. However, the CPP can be submitted in English.

The review period for the application dossier is 60 days for domestic drugs and 90 days for imported drugs.

If the application dossier is approved, the applicant will be issued a marketing registration certificate. The marketing registration certificate is valid for 5 years.

For more information on the new drug registration process in Vietnam, please visit the website of the Drug Administration of Vietnam (DAV).

Conclusion

The updated registration process provides an opportunity to expedite the approval and market entry of drugs. This can bring a positive effect among the public as the medicines are made available at a faster rate. However, there might be challenges with the introduction of a new process for registration.

This includes getting to understand the new process, change of requirements from omission of unnecessary documents to addition of stringent tests that can prove the safety, quality and effectiveness of the drugs. Another challenge is the unfamiliarity with the new online registration system. In spite of all these, the new registration process might shape the future of the Vietnamese healthcare system.

Artixio can help you navigate through the Vietnamese regulatory system for pharmaceuticals. Our regional and subject matter experts stay updated with the ever-evolving regulatory requirements and are keen in providing guidance and strategized solutions to expedite drug market entry. Connect with us through info@artixio.com

FAQ’s

Q. What are the documents to be included in the dossier for registration certificate for circulation of new pharmaceutical drugs in Vietnam?

A. The documents to be submitted for the certificate of registration for circulation are administrative documents, quality documents, preclinical and clinical documents.

Q. What is the timeline for submission of an application for registration certificate renewal?

A. The timeline for the submission of application for the renewal of registration certificate is within 12 months before the expiry of registration certificate. The application for renewal must be submitted by the registration facility.

Q. Who issues CPP and why?

A. The CPP or Certificate for Pharmaceutical Products is issued by the competent authority of the country in which the drug is manufactured. It is to certify that the drug is licensed and is actually being marketed in that country.

Q. What is the time taken to complete the appraisal of an application to extend the registration certificate?

A. From the date of receiving the complete dossier from DAV, the appraisal experts must review and send the appraisal record within 1 month to DAV. There will be an involvement of an advisory council too. The DAV then summarizes and concludes the appraisal record.