Shorten drug registration time

SGGP 08/22/2023 08:31

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

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

Specifically, according to the new regulations, within 3 months from the date of receiving a complete dossier, the Drug Administration shall issue a registration certificate for the circulation of processed drugs and technology transfer drugs. In case of refusal or failure to issue, the Drug Administration shall issue a written reply stating the reasons. Meanwhile, according to the old regulations in Circular 23 of 2013, this period is 6 months. In addition, the implementation of the regulations in Circular 16/2023/TT-BYT will also create opportunities for Vietnamese drug manufacturing enterprises to receive advanced and modern drug manufacturing processes, technologies and techniques, making the most of production capacity; at the same time, ensuring initiative in the production and supply of high-quality drugs, vaccines and biological products for medical examination and treatment of people.

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