The top 10 highlights in Circular no. 08/2022/TT-BYT on Marketing Authorization of drugs and medicinal ingredients

On September 5th 2022, Mr. Do Xuan Tuyen, Deputy Minister of Health, promulgated the new circular no. 08/2022/TT-BYT dated October 20th 2022 which replaces circular no. 32/2018/TT-BYT (dated November 12th 2018) on Marketing Authorization (MA) of drugs and medicinal ingredients.

In this new circular, a series of administrative formalities have been simplified to make it easier for businesses. SEN Pharma would like to summarize 10 highlights in this upcoming circula.

1. Applying information technology to all steps of the drug registration process.
2. Enhancing harmonization with regulations of countries around the world, especially the regulations related to Certificate of Pharmaceutical Product (CPP).
3. Removing the form for the authorization letter (No. 8A/TT & 8B/TT), stipulating the content must be included in this letter, not requiring authorization of the signature of the qualified person.
4. Drugs produced by the same manufacturer, having the same APIs, dosage form, route of administration, and concentration per unit dose (except drugs produced by outsourcing manufacturers and for export purposes only), are licensed for 02 MAs: 01 MA for the trading name, 01 MA for an international nonproprietary name.
5. 11 out of 70 minor variations can be applied at the time of notification to DAV without being validated or approved by competent authorities. However, the manufacturers have to take full responsibility for this.
6. The marketing authorization holder is only allowed to amend and supplement no more than 03 times the application for the grant, renewal, change, or supplement of the marketing authorization.
7. Rolling submission is allowed for vaccines, serum-containing antibodies, and human blood and plasma derivatives.
8. Additional guidelines for the announcement of bio-equivalence drugs; brand-name drugs and reference biologics; publication of the list of domestically produced drugs licensed by any of the SRA members, and list of drugs produced from raw materials (active ingredients) which are granted a CEP certificate for bidding.
9. Announcing the new structure for drug registration numbers including 12 characters and regulations on printing traceability codes on drug labels according to international standards.
10. In terms of the renewal of MA:

• Changing or updating information on label and leaflet is not accepted during the submission of renewal dossiers.
• Capable of removing the following documents: Risk management plan for vaccines; Certificates, Protection titles, Contrast on the transfer of industrial property rights, Documents certifying the origin of raw materials (GACP, CEP, domestic herbal sources, imported herbal sources, …) and related ones; Legal papers of the manufacturer of pharmaceutical ingredients, excipients, capsule shells, semi-finished medicinal herbs, and herbal ingredients, in order to speed up the appraisal of renewal dossiers.

REFERENCES:

1. Thông tư 08/2022/TT-BYT
2. 10 điểm mới nhất cần biết về đăng ký lưu hành thuốc, nguyên liệu làm thuốc Bộ Y tế vừa ban hành