Drug & Raw Material Registration from 2025 in Vietnam

On May 16, 2025, the Minister of Health issued Circular 12/2025/TT-BYT regulating the registration of drugs and raw materials. This Circular will officially take effect from July 1, 2025 and replace Circular 08/2020/TT-BYT, which has been amended and supplemented by Circular 55/2024/TT-BYT. Below, Viet An Law will update some new regulations on drug & raw material registration from 2025 in Vietnam.

Supplementing regulations on responsibilities of drug processing establishments and drug production technology transfer establishments

If previously, Circular 08/2020/TT-BYT, amended and supplemented by Circular 55/2024/TT-BYT, only regulated the responsibilities of drug and drug ingredient manufacturing establishments, Article 5 and Article 6 of Circular 12/2025/TT-BYT added regulations on the responsibilities of drug processing establishments and drug manufacturing technology transfer establishments:

Responsibilities of ordering facilities

The ordering facility is the party that provides part or all of the raw materials, materials, production processes, and technical documents proving that the drug ensures quality, safety, and effectiveness to the facility that accepts the drug processing order to place the order for drug production under the processing contract between the two parties. In addition to implementing the provisions of Article 181 of the Commercial Law and Clause 1, Article 42 of Decree 69/2018/ND-CP on goods processing, the facility that places an order for drug processing is also responsible for:

• Provide the processing facility with: A part or all of materials, and technical documents, including manufacturing process, quality specifications and test methods for starting materials, semi-finished products, finished products and auxiliary materials of the ordered processing stage(s); Other documents relating to application for marketing authorization of processed drug and relating to the drug processing.
• Assume responsibility for the accuracy, legitimacy and truthfulness of technical documents provided for the processing facility in comparison to the dossier on the drug ordered for processing approved by a competent authority.
• Cooperate with the applicant for marketing authorization for processed drug in fulfilling the responsibility in clause 8 Article 3 Circular 12/2025/TT-BYT.

 Responsibilities of sending facilities

The facility transferring drug production technology is the party that owns the technology or the right to use drug production technology pursuant to the provisions of law and transfers the ownership of the technology or the right to use drug production technology to the facility receiving the drug production technology transfer for application in one, some or all stages of the drug production process.

In addition to implementing the provisions of the Law on Technology Transfer, drug production technology transfer facilities must also:

• Provide the receiving facility with: echnical documents, including manufacturing process, quality specifications and test methods for starting materials, semi-finished products, finished products and auxiliary materials of the stage(s) performed using transferred technology; Other documents relating to application for marketing authorization of the drug manufactured adopting transferred technology and relating to the drug manufacturing technology transfer.
• Assume responsibility for the accuracy, legitimacy and truthfulness of technical documents provided for the receiving facility in comparison to the dossier on the drug before technology transfer approved by a competent authority.
• Cooperate with the applicant for marketing authorization for the drug manufactured adopting transferred technology in fulfilling the responsibility in clause 9 Article 3 Circular 12/2025/TT-BYT.

New regulations on deadline for submitting applications for renewal of drug & raw material registration from 2025 in Vietnam

Clause 5, Article 12 of Circular 12/2025/TT-BYT stipulates: An application for renewal of the marketing authorization of a drug or medicinal material must be submitted before its expiration date. An application for renewal of the marketing authorization which is submitted after its expiration date shall be refused by DAV. In this case, the applicant is required to submit an application for issuance of a new marketing authorization.

Thus, while Circular 08/2020/TT-BYT, which was amended and supplemented by Circular 55/2024/TT-BYT, previously stipulated that the deadline for submitting an application for registration renewal is within 12 months before the registration certificate expires, the new regulation does not specify a specific deadline but only requires submission before the date the registration certificate expires.

5 criteria for over-the-counter (OTC) drugs from July 1, 2025

In order to strengthen control over the use of OTC drugs, ensure public safety and approach international standards, Circular 12/2025/TT-BYT has set out new, stricter regulations for OTC drugs.

 4 principles for classification of OTC drugs

• Ensure safety for drug users: Top priority is consumer health.
• Ensure people’s timely access to drugs: People can buy medicine when needed, especially in cases of mild illness..
• Conform to the reality of use and supply of drugs in Vietnam: Conditions of use, storage and supply of medicines must be appropriate to the domestic context..
• Complies with international regulations: Be harmonized with principles and regulations on classification of OTC drugs announced by the States in the region and the world.

5 criteria for determination of OTC drugs

• Safe and effective: It must have been proven to be safe and effective in preventing, alleviating, or treating diseases; have a wide margin of safety to ensure users’ health; have low toxicity, do not produce toxic degradation products during storage and within the human body, do not cause reproductive toxicity, genotoxicity, or carcinogenicity, do not have any unwanted side effects that require supervision or monitoring by physicians or healthcare workers when used according to instructions in its package insert, and do not interact with commonly used medications or foods in a way that could lead to serious adverse reactions;
• Used for short-term treatment and can be self-treated: It is indicated to be used for short-term treatment of common diseases which can be treated by patients themselves without prescription and monitoring by healthcare workers;
• Low risk of dependence or abuse: It rarely causes dependency; does not pose risks of overdose or misuse, which will cause harm to users’ health; does not hide symptom indicators of a serious disease, potentially leading to delayed diagnosis and treatment;
• Easy to use, no technical support required: t must have simple dosage form and route of administration that allow users to take it on their own without the need for technical assistance or instructions from physicians or healthcare workers; not require any special conditions for storage or handling before and after use;
• Contains no toxic ingredients: It does not contain any of herbal ingredients on the List of toxic herbal ingredients announced by Minister of Health.

This new regulation marks a new step forward in improving the quality and safety of OTC drugs, while minimizing risks in drug use in the community. People need to pay attention and comply with the new regulations from July 1, 2025 to protect their health and that of their families.

New criteria for exemption from clinical trial in Vietnam

Pursuant to Article 19 of Circular No. 12/2025/TT-BYT, drugs are exempted from clinical trials in the following cases:

• A generic drug: meeting any of the following criteria:It has bioequivalence data as prescribed in the Circular No. 07/2022/TT-BYT; It is not subject to bioequivalence study reporting upon submission of MAA in Vietnam as prescribed in the Circular No. 07/2022/TT-BYT .
• A new drug (except vaccines): meeting all criteria below: It has been granted marketing authorization in at least one country in the world; It is supported by adequate clinical data; Its clinical data is sufficient for analysis and justification of the impact of ethnic factors of Asian populations on the safety and efficacy of the drug according to ICH-E5 guidelines.
• An herbal drug: granted the marketing authorization before January 01, 2017.

Compared to Article 20 of Circular 08/2020/TT-BYT, which has been amended and supplemented by Circular 55/2024/TT-BYT, this new regulation has set out a number of new criteria such as: for generic drugs, they must not be required to report bioequivalence research data when registering for drug circulation in Vietnam; New drugs (except vaccines) must have Clinical research data with sufficient information for analysis and explanation;….

Amending and supplementing regulations on application dossiers for granting and extending registration marketing authorization certificate for drugs and raw materials

Marketing authorization applications for drugs 

One of the new regulations on drug and raw materials registration from 2025 is the application for marketing authorization certificate. The application for drug registration certificate depends on each case, mainly including:

• Administrative Document: Article 26;
• Quality Document: Article 27;
• Nonclinical Document: Article 24, Article 28;
• Clinical Document: Article 24, Article

Accordingly, for administrative records, compared with Article 26 of Circular 08/2020/TT-BYT, which was amended and supplemented by Circular 55/2024/TT-BYT, the new regulation has eliminated a number of documents in administrative records such as:

• Legal documents of the manufacturing facility of pharmaceutical ingredients, excipients, capsule shells, semi-finished medicinal products, medicinal herbs;
• Certificate of the testing facility;
• Documents assessing compliance with GMP;…

In addition, the new regulation also stipulates the application dossier for a Marketing authorization of a drug in each case, such as: generic drugs, processed drugs, technology transfer drugs, etc.

Application for renewal of marketing authorization of drug/medicinal material

According to Article 41 of Circular No. 12/2025/TT-BYT, application for renewal of marketing authorization of drug/medicinal material includes:

• An application form for renewal of marketing authorization of drug/medicinal material.
• The unexpired CPP (for an imported drug).
• A report on safety and efficacy of the drug during its marketing.

This regulation is intended to comply with the Pharmacy Law 2024 when amending the application for extension of drug and pharmaceutical ingredient circulation registration certificates, thereby simplifying the application and procedures for extension, change and supplementation of drug and pharmaceutical ingredient circulation registration certificates, to avoid interruption of the validity of drug circulation registration certificates and ensure drug supply in all circumstances.

Simplify administrative procedures for granting and renewing marketing authorization of drug/medicinal material

The revised Pharmacy Law 2024  has added regulations on the time limit for granting marketing authorization of drug/medicinal material in Article 56 of the Pharmacy Law 2016, in which there are some cases where the time limit may not exceed 20 days or 15 days.

In order to comply with this regulation, Article 45 of Circular 12/2025/TT-BYT stipulates the time limit for handling procedures for granting marketing authorization of drug/medicinal material as follows:

• Application for issuance of marketing authorization of a drug: not exceeding 12 months;
• Application for issuance of marketing authorization of a drug which is validated using reference to available validation results: not exceeding 09 months;
• Application for issuance of marketing authorization of a processed drug/drug manufactured adopting transferred technology: not exceeding 03 months or not exceeding 09 months.
• Application for issuance of marketing authorization of a new drug which is indicated to serve the prevention and treatment of any group A infectious disease causing an epidemic which has been declared in accordance with regulations of law on prevention and control of infectious diseases: not exceeding 15 days;
• Application for issuance of marketing authorization of a drug in case of prioritized administrative procedures prescribed in clause 5 Article 7 of the Pharmacy Law: not exceeding 06 months;
• Application for issuance of marketing authorization of a medicinal material: not exceeding 06 months.

Regarding the procedure for extending the marketing authorization of drugs and raw materials, it stipulates cases of extending, changing, and supplementing the Marketing authorization without going through the Advisory Council for granting the Marketing authorization of drugs to simplify administrative procedures; reduce the time for extending the Marketing authorization (reduced from 03 months to 01 month for cases of extension without going through the Council).

Above is an update on the new regulations on drug & raw material registration from 2025 in Vietnam. If you have any related questions, please contact Viet An Law for the best advice and support!