You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

October 6, 2022

New Regulations on Drug Registration in Vietnam

Subscribe to Updates

On September 5, 2022, Vietnam’s Ministry of Health (MOH) issued Circular No. 08/2022/TT-BYT on the registration of drugs and drug materials (Circular 08). Circular 08 will come into effect on October 20, 2022, and replace Circular No. 32/2018/TT-BYT and its amendments, which are the current regulations on drug registration.

Below are some noteworthy contents of Circular 08:

  • The requirements on providing a Certificate of Pharmaceutical Product (CPP) are less stringent under the new regulations. For example, a CPP is now only required to include content as stipulated in the WHO’s CPP template. No additional contents—such as specification of finished products, APIs, herbal ingredients, and names and addresses of the API/herbal ingredient’s manufactures as under the current regulations—are required. Another new point is that, for the registration dossiers of new chemical drugs, vaccines, and imported biologicals (except probiotics), applicants are required to submit only one CPP issued by the manufacturing country if the CPP issuing authority is the EMA or any SRA (Stringent Regulatory Authority); no additional CPP/legal document is required as currently.
  • There will be a new option for providing legal documents of the manufacturer of APIs, excipients, capsule shells, semi-finished herbal medicine products, and herbal ingredients to prove compliance with GMP requirements. In particular, in addition to a GMP certificate, manufacturing license stating the manufacturer meets GMP, CPP for API with content satisfying GMP, Certification of Suitability (CEP), or self-evaluation form, it is acceptable if the company submits a Good Agricultural and Collection Practices/GACP certificate (for herbal ingredients) or other legal documents granted by the authorities containing at least the following contents: name and address of the manufacturer, certification that the manufacturer meets GMP requirements, and name of the drug substance/excipient/capsule/semi-finished medicinal material/medicinal ingredient.
  • For vaccines, serums containing antibodies, and derivatives of human blood and plasma, Circular 08 introduces a more lenient policy for receiving registration dossiers. Instead of requiring a complete dossier at the time of submission, the dossier can be submitted without a certificate of analysis, quality specification, or testing method certified by the Vietnam National Institute for Control of Vaccines and Biologicals (NICVB). These papers, which can often take a long time to acquire, can be submitted later in the evaluation process, allowing applicants to secure an earlier filing date.
  • In addition to the procedure for declaring brand-name drugs, the procedures and conditions for classification of a drug as a reference biological are now specified for the first time.
  • A check from the Drug Administration of Vietnam (DAV) on the authenticity of information in legal documents in drug registration dossiers is not always required. Before granting marketing authorization (MA), the check is required in some special cases such as when the CPP shows signs of being erased or modified, or when the legal documents are related to a registrant or manufacturer having drugs registered in Vietnam for the first time. After MA has been granted, the check is required only if the DAV receives information in the form of official documents or email or through mass media reflecting that the status of approval or circulation in the host country requires verification or clarification, or that the foreign manufacturer or applicant has failed to meet operating conditions.
Related Professionals

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

June 5, 2026
On May 25, 2026, Vietnam’s Ministry of Health issued Circular No. 16/2026/TT-BYT governing free-of-charge medicine support programs for medical establishments (Circular 16). Circular 16 will take effect on July 10, 2026, replacing Circular No. 31/2018/TT-BYT, which currently regulates the same subject matter. Circular 16 introduces several significant changes compared to the existing legal framework. Removal of Prior Approval Requirement Under the current regulations, free-of-charge medicine support programs are divided into two categories: (1) entirely free-of-charge provision of medicines for all types of drugs and (2) partially free-of-charge provision applicable only to brand-name drugs under patent protection or drugs whose generic products with identical active ingredients and dosage forms are available in Vietnam. Under the current regulations, partially free-of-charge programs are subject to mandatory registration with the competent authority, while entirely free-of-charge programs could be implemented without prior approval. A key reform under Circular 16 is that it stipulates only entirely free-of-charge medicine support programs applicable to all types of medicines, thereby eliminating the partially free-of-charge category. In addition, free-of-charge medicine support programs may be carried out solely based on a written agreement between the pharmaceutical company and the medical establishment, without any requirement for prior approval from competent authorities prior to implementation. Written Agreement Requirements Circular 16 requires the pharmaceutical company and medical establishment to enter into a written agreement in accordance with a prescribed template. This agreement must include the following compulsory information: Information on the supported medicines Form of support (entirely free-of-charge provision to patients) Quantity of medicines provided Target patient groups and applicable indications Duration of the program Rights and obligations of each party Transitional provisions on the protection of patients’ rights upon completion of the program The agreement may contain other contents as agreed by the parties, provided that these do not contradict applicable laws.
Read More
June 4, 2026
Indonesia’s Minister of Health has issued Decree No. HK.01.07/MENKES/301/2026 on the Affixation of Nutritional Labels and Health Information to Ready-to-Eat Processed Food Products. The decree came into force on April 14, 2026, and was issued to implement the Health Law and Minister of Health Regulation No. 3 of 2026 on Disease Control. The decree requires the inclusion of Nutri-Level labeling on the front-of-pack nutrition labeling (FOPNL) to indicate the product’s nutritional level based on the content of sugar, salt, and fat (“gula, garam dan lemak (GGL)”). Changes from 2024 Draft Regulation The Nutri-Level labeling was previously proposed in 2024 by the Indonesian FDA (BPOM) through a draft regulation concerning nutrition information. While the categories of Nutri-Level labeling remain the same in the issued decree, the content requirements of sugar, salt and fat in the decree are different from the earlier proposal introduced in the 2024 draft BPOM regulation. In addition, the decree has further specified that the content of fat in the Nutri-Level labeling is the content of saturated fat, not total fat as previously proposed in the 2024 draft. The decree requires Nutri-Level labeling to be implemented in beverage products, which is the same as previously proposed in the 2024 draft BPOM regulation. Other food products may gradually become subject to mandatory Nutri-Level labeling under future implementing regulations. Nutri-Level Labeling Food levels as shown by the Nutri-Level labeling are classified into four color-coded categories from A to D: Level A (lowest amount) in dark green Level B in light green Level C in yellow Level D (highest amount) in red The Nutri-Level labeling is represented by the following image. The requirements for each level for sugar, salt, and fat content, based on amounts per 100 milliliters of product in beverage form, are as follows. Nutri-Level information must be
Read More
May 29, 2026
Indonesia’s Food and Drug Authority (BPOM) has issued Regulation No. 7 of 2026 on Drug Promotion and Advertising, establishing an updated framework for promotional activities involving medicinal products in Indonesia. The regulation took effect on April 16, 2026, and supersedes BPOM Regulation No. 2 of 2021 on Drug Advertising Supervision. The new regulation maintains general principles for advertising content, including requirements that advertisements be objective, complete, and not misleading, as further detailed in its annex. It also confirms that advertisements for nonprescription drugs directed to the public must obtain prior approval from BPOM before publication and must be in Bahasa Indonesia. The regulation provides a more comprehensive framework governing how drug promotion is conducted, introducing several notable additions and changes, as described below. Procedure and Requirements for Drug Advertisement Approval To apply for a drug advertisement approval, applicants must create an online account through the dedicated portal SIAPIK. Advertisement approval is available only for registered drugs; unregistered drugs are not eligible for advertisement approval with BPOM. The application must include the advertisement design, along with a translation if the design contains any wording in a foreign language. The submission format varies by media type, requiring, for example, copies in the form of print advertisements for visual media, scripts for audio media, and storyboards for audiovisual media. For online media—including social media—submissions should include any captions, descriptions, and hashtags that form an integral part of the advertising material. The approval timeline takes approximately 3–4 months, as BPOM will generally request additional information or revisions during the verification and evaluation process. Applicants have 20 days to submit any such requested documents. BPOM may also conduct a reevaluation of advertisements that have already received approval, based on monitoring results or new information regarding the safety and quality of the advertised drug. This
Read More
May 11, 2026
Vietnam’s legal framework governing chemicals has undergone significant reform, with the Law on Chemicals No. 69/2025/QH15 (Law on Chemicals 2025) taking effect on January 1, 2026. Together with a comprehensive set of implementing instruments issued in January 2026, including three decrees (No. 24/2026/ND‑CP, No. 25/2026/ND‑CP, and No. 26/2026/ND‑CP) and two circulars (No. 01/2026/TT‑BCT and No. 02/2026/TT‑BCT), the Law on Chemicals 2025 has significantly reshaped chemical registration and management requirements. Determining What Constitutes a “New Chemical” Among the most notable changes introduced under the Law on Chemicals 2025 are the rules governing the registration and management of new chemicals, which must be registered with the authority before being placed on the Vietnam market. Although the concept of new chemical registration was first introduced under the Law on Chemicals 2007, the corresponding registration mechanism has remained largely dormant in practice. Under the Law on Chemicals 2025, a “new chemical” is defined as a substance that is not yet included in Vietnam’s National Chemical Inventory and the list of foreign chemical inventories recognized by the competent Vietnamese authority (List of Foreign Chemicals). On a literal reading, the definition in the new law may suggest that a substance qualifies as a new chemical only if it is absent from both lists. Accordingly, a chemical present in either list should be treated as an existing chemical without the registration burden. However, a different interpretation emerges from Decree 26, which specifically requires registration of “new chemicals” even where such substances already appear in the List of Foreign Chemicals. This implies that inclusion in a recognized foreign inventory does not automatically exempt a substance from new chemical registration in Vietnam. This inconsistency between the statutory definition in the Law on Chemicals 2025 and the implementing provisions of Decree 26 creates significant interpretative and compliance challenges. At
Read More