Handling of Results of Bioequivalence Study Eligibility Assessment for Drugs

Handling the evaluation results of drug bioequivalence testing facilities (illustrative image)

The handling of the evaluation results of drug bioequivalence testing facilities is carried out according to the guidelines in Article 4 of Circular 10/2020/TT-BYT, specifically:

For facilities under the case specified at Point a, Clause 3, Article 1 of this Circular:

- The handling of evaluation results and issuance of Certificate of Eligibility for Drug Business with the scope of drug bioequivalence testing (for drug bioequivalence testing service business facilities), GLP, GCP Certificates or non-issuance of these certificates for facilities eligible for drug bioequivalence testing is carried out in accordance with Article 8 of Circular 04/2018/TT-BYT or Article 11 of Circular 29/2018/TT-BYT.

- For drug bioequivalence testing facilities not subjected to the issuance of Certificate of Eligibility for Drug Business, the GLP, GCP Certificate or Assessment Report meeting GLP, GCP standards is the certification document for the facility to carry out drug bioequivalence testing activities.

- In the case where the drug bioequivalence testing facility already has a GLP, GCP Certificate or an assessment report concluding that the facility meets GLP, GCP standards: After reviewing and evaluating the dossier, the Drug Administration of Vietnam, Ministry of Health, shall submit to the Minister of Health for the issuance of the Certificate of Eligibility for Drug Business with the scope of drug bioequivalence testing (for drug bioequivalence testing service business facilities) or issue a written notice to the facility that it meets the conditions for drug bioequivalence testing according to Form No. 02 issued together with this Circular within 15 days from the date of receiving a complete and valid dossier.

Facilities under the case specified at Point b, Clause 3, Article 1 of this Circular:

- For facilities that do not have a GLP Certificate or an assessment report concluding that the facility meets GLP standards: The handling of evaluation results and issuance of Certificate of Eligibility for Drug Business with the scope of drug bioequivalence testing (for drug bioequivalence testing service business facilities), GLP Certificate or non-issuance of these certificates for facilities eligible for drug bioequivalence testing is carried out in accordance with Article 8 of Circular 04/2018/TT-BYT.

For drug bioequivalence testing facilities not subjected to the issuance of Certificate of Eligibility for Drug Business, when issuing GLP Certificates, the Drug Administration of Vietnam, Ministry of Health, must simultaneously issue a written notice that the facility meets the conditions for drug bioequivalence testing according to Form No. 02 issued together with this Circular.

- For facilities that have been issued a GLP Certificate or an assessment report concluding that the facility meets GLP standards: After reviewing and evaluating the dossier, the Drug Administration of Vietnam, Ministry of Health, shall submit to the Minister of Health for the issuance of Certificate of Eligibility for Drug Business with the scope of drug bioequivalence testing (for drug bioequivalence testing service business facilities) or issue a written notice to the facility that it meets the conditions for drug bioequivalence testing according to Form No. 02 issued together with this Circular within 15 days from the date of receiving a complete and valid dossier.

Facilities under the case specified at Point c, Clause 3, Article 1 of this Circular:

- For facilities that do not have a GLP Certificate or an assessment report concluding that the facility meets GLP standards: the handling of evaluation results is carried out in accordance with Point a, Clause 2 of this Article.

- For facilities that have been issued a GLP Certificate or an assessment report concluding that the facility meets GLP standards:

+ In cases where the assessment report of the drug bioequivalence testing facility concludes that the facility meets the requirements for the residential area, monitoring drug users for the purpose of drug bioequivalence testing, accompanied by emergency equipment as prescribed in the Appendix issued together with this Circular, the Drug Administration of Vietnam, Ministry of Health, shall submit to the Minister of Health for the issuance of the Certificate of Eligibility for Drug Business with the scope of drug bioequivalence testing (for drug bioequivalence testing service business facilities) or issue a written notice to the facility that it meets the conditions for drug bioequivalence testing according to Form No. 02 issued together with this Circular within 10 days from the date of signing the evaluation minutes.

+ In cases where the assessment report of the drug bioequivalence testing facility concludes that the facility needs to rectify and correct: within 05 working days from the date of completion of the on-site evaluation at the bioequivalence testing facility and signing the evaluation minutes, the Drug Administration of Vietnam sends a written request for the bioequivalence testing facility to rectify and correct the deficiencies recorded in the evaluation report.

After completing the rectification and correction, the bioequivalence testing facility must submit a written report accompanied by evidence (documents, photos, videos, certificates) proving that the rectification and correction of the deficiencies recorded in the evaluation report has been completed;

Within 20 days from the date of receiving the rectification report, the Drug Administration of Vietnam, in coordination with the Department of Science, Technology and Training, shall evaluate the rectification results of the bioequivalence testing facility and conclude the compliance status of the bioequivalence testing facility.

In cases where the rectification of the bioequivalence testing facility meets the requirements: the Drug Administration of Vietnam, Ministry of Health, shall submit to the Minister of Health for the issuance of the Certificate of Eligibility for Drug Business with the scope of drug bioequivalence testing (for drug bioequivalence testing service business facilities) or issue a written notice to the facility that it meets the conditions for drug bioequivalence testing according to Form No. 02 issued together with this Circular;

In cases where the rectification of the bioequivalence testing facility does not meet the requirements, the Drug Administration of Vietnam shall send a written response clearly stating the reasons to the requesting facility.

Within 06 months from the date the Drug Administration of Vietnam issues a written request for amendment and supplementation, the bioequivalence testing facility must submit the amended and supplemented dossier as required. After this period, if the bioequivalence testing facility does not amend or supplement, or after 12 months from the submission of the initial application, the supplementary dossier does not meet the requirements, the submitted dossier shall be invalid.

+ In cases where the assessment report of the drug bioequivalence testing facility concludes that the facility does not meet the requirements for the residential area, monitoring drug users for the purpose of drug bioequivalence testing, accompanied by emergency equipment as prescribed in the Appendix issued together with this Circular: within 05 days from the date of completion of the on-site evaluation at the bioequivalence testing facility and signing the evaluation minutes, the Drug Administration of Vietnam shall issue a written notice of non-compliance accompanied by the evaluation report of the compliance status of the bioequivalence testing facility and send to the facility.

Within 05 working days from the date of issuance of the Certificate of Eligibility for Drug Business with the scope of drug bioequivalence testing or the GLP Certificate, the Certificate of GCP compliance, the written notice that the facility meets the conditions for drug bioequivalence testing, the Drug Administration of Vietnam shall publish on the Ministry of Health's electronic portal and the Drug Administration of Vietnam's electronic information page the following information:

- Name and address of the drug bioequivalence testing facility;- Full name of the person responsible for pharmaceutical expertise, pharmaceutical practice certificate number;- Number of the Certificate of Eligibility for Drug Business and the number of the GLP, GCP Certificates (if any);- Expiration date of the evaluation of compliance with the drug bioequivalence testing conditions and the next periodic evaluation date;- Scope of activities of the drug bioequivalence testing facility.

View the full text of the regulations at Circular 10/2020/TT-BYT effective from August 10, 2020.

Thu Ba

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