Pharmaceutical Update: Regulatory Body Approves and Renews Nearly 600 Drug Licenses

The Pharmaceutical Management Agency under the Ministry of Health of Vietnam has announced a new list of approximately 600 drug products and active pharmaceutical ingredients (APIs), both domestically produced and foreign, that have been newly granted or had their marketing authorization licenses renewed. This action aims to ensure supply for public healthcare and epidemic prevention efforts.

Out of the total number of nearly 600 approved products, the breakdown is as follows:

• Domestically Manufactured Products:

  • 404 drug products were newly granted marketing authorization licenses.

  • 42 drug products had their licenses renewed (including 26 drugs/APIs renewed for 5 years and 14 drugs/APIs renewed for 3 years).

• Bioequivalent Drugs:

  • 98 drugs were announced with demonstrated bioequivalence evidence.

The approved products cover a wide range of pharmacological groups, including medicines for treating respiratory infections, osteoarthritis, cardiovascular conditions, hypertension, diabetes, cancer, as well as antiviral drugs, antibiotics, analgesics, and anti-inflammatory agents.

Compliance Responsibilities for Pharmaceutical Businesses

The regulatory agency has imposed several mandatory requirements on drug manufacturers and registration holders to maintain the quality and safety of products circulated in the market:

• Production Standards: Companies must manufacture drugs strictly according to the dossiers and documents registered with the Ministry of Health.

• Labeling: The registration number granted by the Ministry of Health must be printed or affixed onto the drug label.

• Legal Compliance: Full adherence to all current Vietnamese laws and regulations concerning drug manufacturing and distribution.

• Condition Maintenance: Manufacturing and registration facilities must continuously ensure all operating conditions are maintained throughout the validity period of the marketing authorization license.

• Post-Market Surveillance: Close coordination with treatment facilities is required to monitor the safety, efficacy, and adverse drug reactions in Vietnamese patients, followed by regulated reporting.

• Label Updates for Renewals: For renewed drugs that have not yet submitted updated drug label content and package inserts as required, the update process must be completed within 12 months from the date the license was renewed.