GMP assessment for foreign pharmaceutical manufacturers when registering drugs in Vietnam

GMP assessment for foreign pharmaceutical manufacturers is a mandatory step when registering imported drugs in Vietnam to ensure product quality and safety.

Legal basis

• Decree No. 54/2017/ND-CP and its amendments under Decree No. 155/2018/ND-CP and Decree No. 88/2023/ND-CP.
• These regulations provide detailed guidance on the GMP assessment process for foreign pharmaceutical manufacturers.

Cases requiring GMP assessment

• • First-time registration of a drug for marketing authorization in Vietnam.
  • Production line that has not been previously assessed by the Vietnamese Ministry of Health.

• • Renewal of marketing authorization for drugs registered before the effective date of the current regulations, if the manufacturing site has not been assessed for GMP compliance.
  • If the medicinal product is manufactured through multiple stages at different facilities, all facilities involved in each stage of the production process must be assessed.

For more insights into the overall drug registration process in Vietnam, please refer to our detailed guide on Drug Registration in Vietnam.

Forms of GMP assessment

• Dossier appraisal: Applicable to regular manufacturing facilities.
• Recognition or acceptance of inspection results:
  • Facilities located in countries that have signed mutual recognition agreements with Vietnam (e.g., ASEAN countries).
  • Facilities in ICH member countries, Australia, or those inspected and certified by authorities such as USFDA, EMA, TGA, PMDA, or Health Canada.
• On-site inspection: Applied in cases of suspected document authenticity or when the product has been classified as a serious quality violation (level 1) by the Ministry of Health.

Required documents

• Valid GMP certificate or GMP inspection report, explicitly stating that the scope of inspection covers the registered drug or the dosage form of the registered drug.
• Site Master File (according to EU or PIC/S or WHO guidelines), which must also include information relating to the registered drug or its dosage form.
• List of GMP inspections conducted within the past three years, including the most recent inspection report that covers the registered drug or its dosage form (*).
• Periodic Quality Review Report for sterile products (*).

(*) These documents are not required if recognition or acceptance of prior inspection results is applied.

Note: All documents must clearly indicate the inspection scope covering the registered drug or its dosage form.

Submission Authority: Drug Administration of Vietnam – Ministry of Health.

For the complete official regulations on pharmaceutical management, you can refer to the consolidated document issued by the Ministry of Health, available on the Vietnam Government Portal.

GMP assessment of foreign pharmaceutical manufacturing facilities is a crucial step in the drug registration process in Vietnam. Companies should prepare complete and accurate dossiers in compliance with legal requirements to ensure timely review and to enhance the chances of obtaining marketing authorization.