Periodic Evaluation of GLP Compliance Maintenance

According to Article 9 of Circular 04/2018/TT-BYT, the dossier requesting the periodic evaluation for maintaining GLP compliance includes:

- Application requesting periodic evaluation for maintaining GLP compliance;- Updated technical documents regarding the facility conditions, technical conditions, and personnel of the testing facility (if there are changes);- Summary report on the testing activities of the testing facility for the last 3 years from the previous evaluation date (excluding sudden evaluations, inspections, checks by the Ministry of Health, Department of Health) to the date of the periodic evaluation request.

The periodic evaluation for maintaining GLP compliance is regulated as follows:

- The periodic evaluation period for maintaining GLP compliance at the testing facility (including non-commercial testing facilities) is every 3 years, from the end date of the previous evaluation (excluding sudden evaluations, inspections, checks by the Ministry of Health, Department of Health).

In case the facility is only engaged in the bioequivalence testing service of drugs, the periodic evaluation is conducted according to the regulations of the Minister of Health on Good Clinical Practice for drug trials.

- Every November, the Drug Administration Department publishes on its electronic information page a plan to periodically evaluate the maintenance of GLP compliance of testing facilities for the following year.

- Based on the periodic evaluation plan published by the Drug Administration Department, the testing facility shall submit a dossier requesting the periodic evaluation according to Clause 7, Article 9 of Circular 04/2018/TT-BYT to the Drug Administration Department at least 30 days before the evaluation date as per the plan published by the Drug Administration Department.

Example: If the estimated periodic evaluation date at testing facility A is August 18, 2018, then testing facility A must submit the evaluation request dossier to the Drug Administration Department before July 18, 2018.

- In case the testing facility does not submit the evaluation request dossier within the prescribed time limit, within 15 days from the due date for submitting the dossier, the Drug Administration Department will issue a written request for the testing facility to explain the reason for not submitting the periodic evaluation request dossier.

- Within 30 days from the date the Drug Administration Department issues a written request for the testing facility to explain the reason for not submitting the periodic evaluation request dossier, if the testing facility does not submit the periodic evaluation request dossier as prescribed, the Drug Administration Department shall submit a proposal to the Minister of Health to make a decision to revoke the Certificate of eligibility for pharmaceutical business of the pharmaceutical business facility according to Clause 2, Article 40 of the Pharmaceutical Law or issue a written request for cessation of testing activities for non-commercial testing facilities.

- After submitting the periodic evaluation request dossier for maintaining GLP compliance within the prescribed time, the testing facility is allowed to continue its testing activities within the scope specified in the Certificate of eligibility for pharmaceutical business or GLP Certificate for non-commercial testing facilities, from the date of dossier submission until the periodic evaluation result is available.

See also: Circular 04/2018/TT-BYT effective March 26, 2018.

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