Criteria for classification of proprietary drugs and reference biologicals in Vietnam

Criteria for classification of proprietary drugs and reference biologicals in Vietnam (Internet image)

Regarding this issue, LawNet would like to answer as follows:

1. Concept of original brand name drug and reference biological in Vietnam

- Original brand name drug means the first drug that is licensed for free sale based on sufficient data about its quality, safety, and efficacy.

Reference biological means a biological licensed for free sale in Vietnam based on sufficient data about its quality, safety, and efficacy.

(Clause 11 and 16, Article 2 of the Law on Pharmacy 2016)

2. Criteria for classification of proprietary drugs and reference biologicals in Vietnam

Specifically, in Clause 1, Article 9 of Circular 08/2022/TT-BYT, the criteria for classification of proprietary drugs and reference biologicals in Vietnam are as follows:

(1) A drug which has been granted marketing authorization in Vietnam shall be classified as proprietary drug or reference biological when it meets all of the following criteria:

- The safety and efficacy data is sufficient as prescribed in Article 13 of of Circular 08/2022/TT-BYT;

With regard to a reference biological, quality, preclinical and clinical documents and data must be sufficient to prove that it is developed as a biological product other than a biosimilar product from the first stage;

- The drug has been granted the marketing authorization by one of the regulatory authorities mentioned in Clause 9 Article 2 of of Circular 08/2022/TT-BYT, except for new drugs that are manufactured in Vietnam.

(2) In case a drug has been declared as a proprietary drug or reference biological by the Ministry of Health of Vietnam, and the drug processing is conducted in Vietnam or one, some or all of its manufacturing processes are transferred to a manufacturer in Vietnam, the proprietary drug or reference biological and the drug products processed or manufactured in Vietnam must satisfy all of the following criteria:

- They have the same formula;

- The manufacturing processes are the same;

- The material quality specifications are the same;

- The drug product specifications are the same;

In case of any changes to the criteria in this Point or any other changes in the quality of the drug, they must be approved by the drug regulatory authority of the country of manufacture or a regulatory authority mentioned in Clause 9 Article 2 of of Circular 08/2022/TT-BYT that has granted marketing authorization of that drug or the applicant must provide data proving that the drug manufactured in Vietnam has equivalent quality with the proprietary drug or reference biological before the drug is processed or technology transfer is made.

(3) In case of change of the manufacturer of a drug declared as a proprietary drug or reference biological, the drug granted the new marketing authorization of the new manufacturer will also be classified as a proprietary drug or reference biological if the applicant makes a written request and all of the following criteria are satisfied:

- The drug has been granted the marketing authorization by one of the regulatory authorities mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT;

- The drug satisfies all of the criteria specified in Point b Clause 1 of Article 9 of Circular 08/2022/TT-BYT.

In case of any changes to the criteria in Point b Clause 1 of Article 9 of Circular 08/2022/TT-BYT or any other changes in the quality of the drug, they must be approved by the drug regulatory authority of the country of manufacture or a regulatory authority mentioned in Clause 9 Article 2 of Circular 08/2022/TT-BYT that has granted marketing authorization of that drug or the applicant must provide data proving that the drug manufactured by the new manufacturer has equivalent quality with the proprietary drug or reference biological before the manufacturer is changed.

Thanh Rin

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