What are regulations on documents on quality in applications for issuance and amendment of COVID-19 vaccine marketing authorizations in Vietnam?

What are regulations on documents on quality in applications for issuance and amendment of COVID-19 vaccine marketing authorizations in Vietnam? - image from internet

Pursuant to Article 16 of the Circular 11/2021/TT-BYT stipulating documents on quality in applications for issuance and amendment of COVID-19 vaccine marketing authorizations in Vietnam:

Documents on quality shall adhere to regulations in Clause 7 Article 25 of Circular No. 32/2018/TT-BYT, guidelines in Part II of ASEAN Common Technical Document (ACTD) or Module 3-ICH-CTD and the following regulations:

1. Batch release certificate shall be issued by an analyzing unit appointed by the competent authority of the manufacturing country.

2. In case the applicant cannot provide the document mentioned in Clause 1 of this Article, the applicant shall provide certificates of analysis, quality standards and analyzing methods confirmed by analyzing units appointed by the competent authority of the manufacturing country according to regulations in Clause 5 Article 1 of Circular No. 03/2020/TT-BYT dated January 22, 2020 by the Minister of Health on amendments to some Articles of the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of Health on quality of pharmaceutical products and pharmaceutical starting materials.

3. Documents on manufacturing process assessment and stability analysis must include data on 03 commercial-sized batches.

If data on 03 commercial-sized batches cannot be provided, provide data on at least 01 commercial-sized batch and 02 pilot-sized batches (at least 1/10 of the commercial size) and comparison table for manufacturing processes and stability analyses of commercial-sized batch(s) and pilot-sized batches, vaccine batches used in the clinical trial and certificate of analysis of each batch.

4. Regarding documents on quality of vaccines with transferred technology that have unexpired Vietnamese marketing authorizations when they are pre-technology transfer vaccines

Documents on quality of vaccines with transferred technology shall comply with the guidelines in Clauses 1, 2 and 3 of this Article and include the following documents:

a) Comparison table for differences (if any) between the pre-technology transfer vaccine and vaccine with transferred technology and documentary proof according to regulations in Appendix II to Circular No. 32/2018/TT-BYT and Clause 2 Article 18 of this Circular;

b) Documents on active ingredients of the vaccine with transferred technology provided by the receiving facility upon change of an active ingredient manufacturing facility of the pre-technology transfer vaccine;

c) Documents of the finished product of the vaccine with transferred technology shall be formulated by the receiving facility and include the following documents:

- Report on manufacturing process assessment (for manufacturing stages done at the receiving facility);

- Report on assessment of suitability of analyzing procedure (may be replaced by documents on analyzing procedure transfer formulated by the transferring facility and receiving facility);

- Data on batch analysis and certificate of analysis of the finished product.

5. If the pre-technology transfer vaccine has not been granted Vietnamese marketing authorization or its Vietnamese marketing authorization has expired, documents on quality of the vaccine with transferred technology shall adhere to the guidelines in Clause 4 of this Article and documents on quality of the pre-technology transfer vaccine shall comply with the guidelines in Part II-ACTD or Module 3-ICH-CTD.

6. For vaccines undergoing secondary packaging in Vietnam

All documents on vaccine quality prior to secondary packaging in Vietnam shall conform to Part II-ACTD or Module 3-ICH-CTD and Clauses 1, 2 and 3 of this Article if the vaccine has not been granted Vietnamese marketing authorization or its Vietnamese marketing authorization expires prior to secondary packaging in Vietnam.

Best regards!