Vietnam’s New Regulations on Drug Regulation

Introduction

Vietnam’s pharmaceutical regulatory landscape is undergoing significant transformation with the issuance of Circular No. 12/2025/TT-BYT by the Ministry of Health, set to take effect on July 1, 2025. This new regulation consolidates and replaces several prior circulars, introducing a modernized drug registration and classification approach. Understanding these changes is essential for multinational pharmaceutical companies, local manufacturers, and regulatory professionals to ensure compliance and maintain market access in one of Southeast Asia’s fastest-growing life sciences markets. In this post, we break down the key provisions of Circular 12, highlight what’s new, and offer practical insights for navigating Vietnam’s evolving regulatory framework.

Regulation of non-prescription drugs

Circular 12 eliminates the detailed list of over-the-counter drugs (OTC) previously provided in Circular No. 07/2017/TT-BYT.  Circular 12 does not rely on a fixed list for classification. Instead, it introduces a new framework that relies on certain principles, criteria, and methods for determining the status of non-prescription/OTC drugs. 

In particular, the new framework relies on the principles of:

a)      ensuring safety for drug users;

b)     ensuring timely access to medication for the population;

c)      reflecting actual usage and supply conditions of drugs in Vietnam; and

d)     aligning with international and regional principles and regulations on non-prescription/OTC drug classification.

The following criteria have to be met for a drug to be classified as a non-prescription/OTC drug:

a)      proven safety and efficacy;

b)     indicated for short-term treatment of common conditions that can be self-diagnosed and treated by patients;

c)      low risk of dependence, overdose, or misuse, and does not mask symptoms of serious illness;

d)     has a simple dosage form and route of administration, not requiring technical assistance, no special storage or handling requirements; and

e)      having no toxic herbal ingredients as defined by the Ministry of Health.

 The following methods are used for classifying a drug as a non-prescription/OTC drug:

 1.      generic drugs follow the classification of the originator drug (if already registered in Vietnam);

2.      if the originator is not approved in Vietnam, classification follows drugs with the same actives/form/formulation in countries with “stringent regulatory authorities” (SRAs);

3.      classification based on similar drugs approved in Vietnam; or

4.      In all other cases, the Advisory Council decides based on the above criteria and principles.

This new framework enhances safety, ensures timely access, reflects usage and supply conditions, and aligns with international standards.

Drugs that have already been approved will retain their classification as either prescription or non-prescription drugs throughout the validity of their marketing authorization (MA).  Reclassification will be considered when the MA is renewed.  If a change in classification is required, the MA holder will be required to submit a variation registration dossier to the Drug Administration of Vietnam (DAV).

For drug registration dossiers currently under evaluation by DAV, the classification will be assessed according to the new provisions in Circular 12. 

Drug registration

The new regulations for Circular 12 loosen the requirements of providing a Certificate of Pharmaceutical Product (CPP).  For drug registration, a single CPP will be sufficient, provided:  (1) it is issued by the competent authority of the manufacturing country or by an authority from a country that is a member of the European Medicines Agency (EMA) or a Stringent Regulatory Authority (SRA); and (2) that competent authority confirms that the drug is licensed and being actively marked in that country.  Contrast this with the previous regulations, in which an additional CPP or similar legal document would be required under certain circumstances.

For a dossier for drug registration relying on reference results of a registration dossier reviewed by authorities outside of Vietnam, the dossier for registration must:

1.      Be submitted in Vietnam no later than five years from the date the EMA or SRA first approves the drug; and

2.      Include: (a) an assessment report issued by the EMA or SRA; and (ii) a comparison table of the similarities between the registration dossier in Vietnam and the version approved by the EMA or SRA.

Marketing Authorization Extensions

The validity period of marketing authorization is 5 years by default, although a 3-year marketing authorization is issued for drugs subject to extended safety and efficacy monitoring.

Under Circular 12, a dossier extension can be submitted any time before the expiration of the marketing authorization. If a renewal application is submitted before the marketing authorization expires, the existing marketing authorization remains valid until a new decision is issued (approval or rejection), or until the DAV suspends the marketing authorization due to safety concerns or document authenticity issues. If the renewal application is submitted after the expiration of the marketing authorization, it will not be accepted. In that case, the applicant must submit a new application for issuance, not renewal.

Timeline and Limits for Submitting Supplemental Dossiers

The deadline for submitting a supplemental registration dossier in response to a deficiency letter from DAV is shortened to six months.  Additionally, a maximum of two rounds of supplementation will be permitted in response to requests from DAV experts.  A third round of supplementation will only be allowed if additional requirements are raised during the second round.  However, these limits on supplementation do not apply if the Advisory Council for Drug Registration issues supplementation requests.

Final Thoughts

Vietnam’s adoption of Circular 12 marks a decisive step toward harmonizing its drug regulatory system with international standards. By moving away from rigid lists in favor of principle-based classification for non-prescription drugs and streamlining requirements for Certificates of Pharmaceutical Product, the Ministry of Health is signaling its commitment to patient safety and timely access to medicines. The revised dossier submission and supplementation procedures reflect a drive for greater efficiency and predictability in the registration process.

These changes present both opportunities and challenges for stakeholders. Companies should closely review their current and pending dossiers to ensure alignment with the new requirements, particularly regarding classification and documentation. The transition period may require proactive engagement with the DAV to clarify expectations and avoid delays.

This post was written by Lisa Mueller and Kian Hoe of Davies, Collison, and Cave.