Vietnam Pharmaceutical Registration and Approval

Drug registration in Vietnam falls under the responsibility of the Drug Administration of Vietnam (DAV), which is a unit under the Vietnamese Ministry of Health. In order to sell drugs in Vietnam, approval from the DAV is required, as well as a separate import permit. There are two categories of drugs intended for distribution in Vietnam: prescription drugs and non-prescription drugs. The procedure for registering a drug in Vietnam with the DAV is outlined below:

  • The first step is submitting an application dossier that complies with the ASEAN/ICH Common Technical Dossier requirements.
  • The application dossier for a new drug or biological product registration consists of four parts: product information dossier, Preclinical dossier, Clinical dossier, and Quality dossier.
  • The second stage involves the validation and evaluation of the application dossier by the DAV's Drug Evaluation Council, a process that typically lasts between 12 and 18 months.
  • The third step involves addressing any deficiencies in the application dossier, if necessary. In case there are any shortcomings, the DAV will send an official letter to the applicant, asking them to provide additional documents or clarify any issues related to the application dossier.
  • The fourth and final step involves the issuance of a registration number or marketing authorization (MA) that specifies a unique registration number for the drug.

  • Pharmaceutical multinational corporations (MNCs) have two options for bringing their products into Vietnam. The first option is to sign importation and distribution agreements with local pharmaceutical companies, which is also known as "Direct Sale." The second option is to use their direct importation right and then utilize the services of local distributors, which is called "Direct Importation."

    At the end of 2022, the MoH issued a new set of regulations for drug registration in Vietnam. The requirements for a Certificate of Pharmaceutical Product (CPP) are now less stringent. The option for providing legal documents to demonstrate adherence to GMP standards has been expanded to include additional types of documents. The registration process for vaccines, serums containing antibodies, and derivatives of human blood and plasma has become more flexible.

    To learn more about how PBM can help you register your drug products in Vietnam, please contact us.