Documentation and procedures for bioequivalence studies in Vietnam

Documentation and procedures for bioequivalence studies in Vietnam (Internet image)

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

1. Documentation and procedures for bioequivalence studies in Vietnam

Documentation and procedures for bioequivalence studies in Vietnam according to Article 101 of the Law on Pharmacy 2016 are as follows:

- Bioequivalence study documents include:

+ An application for permission for bioequivalence study;

+ Documents containing information about the drug;

+ The bioequivalence study outlines and description;

+ Academic records of researchers;

+ Registration forms of the subjects;

+ Drug label.

- Procedures for bioequivalence study:

+ Register the bioequivalence study;

+ Approve the bioequivalence study;

+ Conduct the bioequivalence study;

+ Approve the bioequivalence study result;

2. Rights and responsibilities of the clinical trial service provider in Vietnam

The rights and responsibilities of the clinical trial service provider (hereinafter referred to as the investigator) in Vietnam according to Article 99 of the Law on Pharmacy 2016 are as follows:

- The investigator has rights to:

+ Carry out clinical trial and biological fluid analysis in bioequivalence testing.

If only biological fluid analysis is carried out, it may sign a contract or cooperate with a provider of clinical trial services that fulfills Good Clinical Practice requirements to carry out clinical trial in the process of bioequivalence study;

+ Conduct bioequivalence studies as prescribed;

+ Import, purchase chemicals, reference materials, and drug samples serving bioequivalence studies;

+ Use bioequivalence study results under agreements with the sponsors.

- The investigator has obligations to:

+ Take responsibility for the bioequivalence study results;

+ Take responsibility for the safety of subjects and pay compensation for those who suffer injuries for which the investigator is responsible;

+ Ensure truthfulness and objectivity in bioequivalence studies;

+ Be independent in terms of finance and personnel from the sponsors.

3. Phases of bioequivalence study and drugs required to undergo bioequivalence study in Vietnam

Phases of bioequivalence study and drugs required to undergo bioequivalence study in Vietnam according to Article 96 of the Law on Pharmacy 2016 are as follows:

- A bioequivalence study consists of the following phases:

+ Clinical trial phase: a phase in which a comparative drug and a the tested drug which is proven safe and effective are tested to compare their bioavailability in the subjects;

+ Human biological fluid analysis: a phase in which concentrations of a comparative drug and a the tested drug in specimens of the subjects are analyzed in order to compare their bioavailability and prove their bioequivalence;

- A generic drug must undergo bioequivalence study if it contains an active ingredient or has a dosage form that is on the List of active ingredients and dosage forms required to undergo bioequivalence studies promulgated by the Minister of Health.

4. Rights and responsibilities of owners of the drugs undergoing bioequivalence study in Vietnam

Rights and responsibilities of owners of the drugs undergoing bioequivalence study (hereinafter referred to as the sponsor) according to Article 98 of the Law on Pharmacy 2016 are as follows:

- The sponsor has the rights to:

+ Select a qualified organization in terms of equipment and personnel to run the bioequivalence study;

+ Acquire the full ownership of the bioequivalence study result.

- The sponsor has the obligations to:

+ Pay compensation for the subjects who suffer injuries because of the bioequivalence study;

+ Sign a bioequivalence study contract with the investigator;

+ Take legal responsibility for the quality and safety of the drug provided.

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