Summary of penalties for violations against regulations on drug testing, clinical trial in Vietnam

Summary of penalties for violations against regulations on drug testing, clinical trial in Vietnam (Illustration)

Decree 117/2020/ND-CP stipulates penalties for violations against regulations on drug testing, clinical trial in Vietnam:

1. A fine ranging from VND 10.000.000 to VND 15.000.000 shall be imposed for commission of one of the following violations:

- Failing to submit a report on changes, accompanied by relevant technical documents, to the receiving authority when expanding the existing laboratory, making major repairs or changes in structure or floor plan of the laboratory, or changing the auxiliary system or principle of design or operation of utility systems that may affect the laboratory environment;

- A drug testing service provider takes drug samples against regulations on drug sampling of the Ministry of Health.

2. A fine ranging from VND 15.000.000 to VND 20.000.000 shall be imposed for commission of one of the following violations:

- Providing drug/pharmaceutical starting material testing service, bioequivalence study service or clinical trial service against or beyond the scope specified in the certificate of eligibility for pharmacy business or the scope of inspection of GLP (Good laboratory practices) compliance or GCP (Good clinical practice) compliance of a non-commercial pharmacy business establishment;

- Disclosing personal information of participants in the bioequivalence study without their consent;

- Concealing information or failing to provide participants with adequate and truthful information on the bioequivalence study, its procedures and possible risks.

3. A fine ranging from VND 20.000.000 to VND 30.000.000 shall be imposed for commission of one of the following violations:

- A non-commercial pharmacy business establishments provides bioequivalence study or clinical trial service without possessing a valid certificate of eligibility for pharmacy business or passing the inspection of GCP compliance;

- Changing any documents included in the approved bioequivalence study dossier or bioequivalence study outline;

- Failing to submit reports on GLP compliance as prescribed by law;

- Only maintaining the GLP compliance at level 3;

- Failing to submit a report on changes, accompanied by relevant technical documents, to the authority receiving the application for inspection of GLP compliance when changing the location of the existing laboratory or opening a new laboratory within the same business location.

4. A fine ranging from VND 30.000.000 to VND 40.000.000 shall be imposed for forging or falsifying drug testing/analysis results.

See detailed penalties at Decree 117/2020/ND-CP effective from November 15, 2020.

Ty Na

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