When applying for registration of marketing authorization of drugs and medicinal ingredients, what are drugs eligible for quick validation in Vietnam?
- When applying for registration of marketing authorization of drugs and medicinal materials, what are drugs eligible for quick validation in Vietnam?
- What are drugs eligible for simplified validation procedures?
- What are the regulations on the authority to approve issuance of marketing authorization of drugs and medicinal materials in Vietnam?
When applying for registration of marketing authorization of drugs and medicinal materials, what are drugs eligible for quick validation in Vietnam?
Pursuant to Clause 1, Article 33 of Circular 08/2022/TT-BYT stipulating drugs eligible for quick validation in Vietnam.
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.
When applying for registration of marketing authorization of drugs and medicinal ingredients, what are drugs eligible for quick validation in Vietnam?
What are drugs eligible for simplified validation procedures?
The drugs eligible for simplified validation procedures are specified in Clause 2, Article 33 of Circular 08/2022/TT-BYT.
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.
What are the regulations on the authority to approve issuance of marketing authorization of drugs and medicinal materials in Vietnam?
According to the provisions of Article 34 of Circular 08/2022/TT-BYT as follows:
Authority to approve issuance, renewal, revision of marketing authorization of drugs and medicinal materials in Vietnam
1. The Drug Administration of Vietnam and authorities decided by the Minister of Health of Vietnam (hereinafter referred to as “validating units”) shall validate and consider granting applications for issuance, renewal and revision of marketing authorization of drugs and medicinal materials, except for regulations in Point b Clause 2 of this Article.
2. The Drug Administration of Vietnam shall:
a) issue, renew and approve revision of the marketing authorization of drugs, declaration of proprietary drugs, reference biologicals, drugs with demonstrated bioequivalence on the basis of opinions given by the Advisory Board in each specific case or general guidelines given by the Advisory Board applied to each type of revision, except the case in Point b of this Clause;
b) publish on its website the minor variations to the marketing authorization of drugs/medicinal materials that only require notification.
Thus, the Drug Administration of Vietnam and authorities decided by the Minister of Health of Vietnam (hereinafter referred to as “validating units”) shall validate and consider granting applications for issuance, renewal and revision of marketing authorization of drugs and medicinal materials.
- The Drug Administration of Vietnam shall issue, renew and approve revision of the marketing authorization of drugs, declaration of proprietary drugs, reference biologicals, drugs with demonstrated bioequivalence on the basis of opinions given by the Advisory Board in each specific case or general guidelines given by the Advisory Board applied to each type of revision.
Except for the case of publishing on its website the minor variations to the marketing authorization of drugs/medicinal materials that only require notification.
LawNet
