09 cases of drugs eligible for quick validation in Vietnam 2023

09 cases of drugs eligible for quick validation in Vietnam 2023 (Internet image)

1. 09 cases of drugs eligible for quick validation in Vietnam 2023

Clause 1, Article 33 of Circular 08/2022/TT-BYT stipulates the cases of drugs eligible for quick validation in Vietnam as follows:

A marketing application will be eligible for quick validation procedures if one of the following conditions is satisfied:

- A drug included in the list of rare drugs announced by the Minister of Health of Vietnam;

- Drugs serving urgent needs for national defense and security, epidemic control or disaster recovery;

- Domestic drugs that are manufactured by production lines that satisfy GMP, GMP-EU, GMP-PIC/S standards and equivalent standards within 18 months from the issuance date of the GMP certificate;

- Vaccines that have been prequalified by WHO; vaccines used for national expanded immunization programs;

- Specialty drugs, drugs with special dosage forms where not more than 02 similar drugs (with the same active ingredients, dosage form, content or concentration) have an unexpired marketing authorization in Vietnam when the application is submitted, including:

+ Antineoplastic drugs;

+ Next-gen antiviral drugs;

+ Next-gen antibiotics;

+ Drugs for treatment of haemorrhagic fever, tuberculosis, malaria;

+ Immunosuppresive drugs used in organ transplantation.

- Drugs that can be domestically manufactured, including:

+ Antineoplastic drugs, vaccines, biologicals, next-gen antiviral drugs, next-gen antibiotics, and immunosuppresive drugs used in organ transplantation that are manufactured in Vietnam under a processing agreement or technology transfers agreement;

+ Herbal drugs under a national, ministerial or provincial research which has been accepted; drugs wholly obtained from domestic herbal ingredients that satisfy GACP standards;

+ New domestic drugs that have undergone clinical trial in Vietnam;

- New antineoplastic drugs, next-gen antiviral drugs, next-gen antibiotics, and reference biologicals;

- Proprietary drugs that are manufactured in Vietnam under a processing agreement or technology transfer agreement;

- Drug whose manufacturer is changed resulting in application for issuance of a new marketing authorization as prescribed in Point b Clause 2 Article 55 of the Law on Pharmacy.

2. 04 cases of drugs eligible for simplified validation in Vietnam 2023

Cases of drugs eligible for simplified validation in Vietnam specified in Clause 1, Article 33 of Circular 08/2022/TT-BYT are as follows:

A marketing application will be eligible for simplified validation procedures if all of the following conditions are satisfied:

- The drug is manufactured in a factory that periodically undergoes GMP inspection by the Drug Administration of Vietnam;

- The drug is included in the list of OTC drugs;

- The dosage form of the drug is not modified-release;

- The drug is not directly applied to the eye.

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