Shorten the drug registration time.

SGGP 22/08/2023 08:31

The Ministry of Health has just issued Circular No. 16/2023/TT-BYT (effective from October 1, 2023) regulating the registration for circulation of drugs manufactured under contract and drugs produced through technology transfer in Vietnam.

According to the Ministry of Health , Circular 16/2023/TT-BYT, with 5 chapters, 23 articles, and 2 appendices, is an important legal basis for attracting investment and transferring technology for drug production, especially for original branded drugs and patented inventions.

Specifically, according to the new regulations, within 3 months from the date of receiving complete dossiers, the Drug Administration of Vietnam will issue a registration certificate for contract-made drugs and drugs with transferred technology. If the certificate is not issued or not yet issued, the Drug Administration will provide a written response stating the reasons. Meanwhile, under the old regulations in Circular 23 of 2013, this period was 6 months. In addition, the implementation of the regulations in Circular 16/2023/TT-BYT will also create opportunities for Vietnamese drug manufacturers to receive advanced and modern drug manufacturing processes, technologies, and techniques, maximizing their production capacity; while ensuring proactive production and supply of high-quality drugs, vaccines, and biological products for the medical examination and treatment of the people.

Source: https://www.sggp.org.vn/rut-ngan-thoi-gian-dang-ky-thuoc-post702532.html