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​ 

March 20, 2026
Myanmar has introduced a comprehensive new regulatory framework for alcoholic beverages that will impose stricter controls on production, distribution, advertising, and sales. On March 7, 2026, the National Defence and Security Council issued a new Excise Law (NDSC Law No. 13/2026), repealing the Excise Act of 1917. The law, which has not yet entered into force, will take effect on a date to be specified in a separate notification—likely within this year. The new Excise Law establishes clearer definitions, introduces multiple categories of excise licenses and permits, and significantly expands prohibitions and compliance obligations for businesses operating in the alcohol sector. Many operational details will be clarified through implementing rules and notifications. Scope and Definitions The new law defines “excise” to cover alcoholic liquor and excisable articles. Alcoholic liquor is broadly defined as any liquid containing more than 0.5% ethyl alcohol, including beer, wine, toddy sap, fermented liquor, and any other liquid declared as alcohol by notification of the relevant ministry, excluding denatured alcohol. Alcoholic liquor is further categorized into country liquor, foreign liquor, and international‑standard domestically produced liquor. Excise Licensing The law also introduces a more detailed licensing regime. The following types of liquor excise licenses are available: Production Production of value-added products Bottling Distribution Sales Other excise‑related businesses designated by General Administrative Department (GAD) notification The GAD will prescribe the licensing fees, requirements, and conditions for each category through notifications issued with the approval of the Ministry of Home Affairs. The GAD may also, with the approval of the Ministry of Home Affairs, prescribe quantities and volumes of alcoholic beverages that may be possessed without a liquor license. No such prescribed quantities have yet been issued. Holders of excise licenses for manufacturing, production of value-added products, or bottling must obtain approval from the relevant government department or
Read More
February 26, 2026
Laos’ Food and Drug Department (FDD) has been using a new online registration system for drugs since the beginning of the year. The system, which was implemented following the November 2025 issuance of Notice No. 5960/FDD, became the official pathway for submissions on January 1, 2026. Since that date, paper-based registrations have no longer been accepted. This marks a significant advancement in the digitalization of regulatory processes in Laos. As the online system is now the exclusive platform for registration, renewal, and amendments, companies that have not yet aligned their processes to the new system should act promptly to ensure a smooth transition. To assist with this, the FDD will conduct periodic training sessions on the use of the online registration system, which will be delivered either in person or remotely, depending on operator demand. To start using the system, drug and medical device manufacturers, as well as import-export companies, that have not yet registered must submit a formal request identifying the authorized personnel who will access the platform, after which they will be issued user accounts and access codes. Each request must be accompanied by the company’s enterprise registration certificate (incorporation certificate), a copy of the identity card or passport of each designated user, and a scanned copy of their signature. There is no restriction on the number of users per company, allowing flexibility to meet operational needs. Companies that already hold accounts and access codes from the trial phase may continue using them and may apply for additional accounts if needed. Additional Requirements The new system also introduces a standardized format for drug registration numbers. For example, an import drug registration number such as 06 I 4040/15 will be changed to 06-IM-04040-15, and a domestic drug registration number such as 06 L 4040/15 will be changed to
Read More
February 25, 2026
On February 18, 2026, Myanmar’s Ministry of Health issued Order No. 8/2026 announcing the prohibition of electronic smoking devices and related products under the Essential Supplies and Services Law 2012, thus outlawing their use, storage, and trade. The ban covers e‑cigarettes, heated tobacco products, electronic shisha, and all related components and accessories, including devices, parts, batteries, chargers, and flavored liquids (regardless of nicotine content). Prohibited activities include importing, exporting, selling, distributing, possessing, storing, transporting, and using these products, with immediate effect. Regulatory Compliance Businesses and individuals should promptly review their inventories, operations, and commercial arrangements to ensure compliance. Affected products should be withdrawn from the market, and relevant licensing, registration, and reporting obligations should be reviewed. Companies are also advised to update internal compliance procedures and coordinate with relevant authorities as necessary.
Read More
January 8, 2026
Thailand’s approach to cannabis regulation has moved quickly from broad access to a medical, prescription‑only system. The latest government regulation classifies the cannabis flower as a controlled herb under the Thai Traditional Medicine Wisdom Act. The latest rules ban advertising and recreational sales, allow sales only to patients with prescriptions (up to 30 days), and require flowers to come from GACP‑certified (Good Agricultural and Collection Practices) farms. More importantly, cannabis dispensaries can only sell to patients presenting valid prescriptions issued by one of seven professions—medical doctors, Thai traditional practitioners, applied Thai traditional practitioners, traditional Chinese medicine practitioners, pharmacists, dentists, and folk healers—consistent with approved clinical indications. Noncompliance risks license suspension or revocation, and criminal penalties of up to one year’s imprisonment or a THB 20,000 fine. The dispensary‑only model that proliferated in Thailand in recent years is expected to end soon, as the rules will push all cannabis dispensaries into medical settings or retail pharmacies. Dispensaries must convert into medical establishments—clinics, pharmacies, or traditional pharmacies—complete with on‑site licensed practitioners as well as budtenders; strong controls for storage, hygiene, odor, and smoke; and facilities for record-keeping. All flowers dispensed or exported must come from GACP‑certified farms. If the government ends dispensaries outright and forces a conversion to clinics or pharmacies, compensation will not be automatic at the outset. As a result, business operators should plan for compliance and repurposing under the Medical Facilities Act, Modern Drug Act, and Herbal Product Act, which regulate medical clinics, modern pharmacies, and traditional medicine pharmacies, respectively. The table below summarizes the required licenses for clinics, pharmacies, and traditional medicine pharmacies selling cannabis flowers in Thailand. Aside from the specific listed licenses, all three types of establishments must also obtain a license to sell a controlled herb (cannabis flowers) from the Department of Thai Traditional
Read More