|MINISTRY OF HEALTH
DRUG ADMINISTRATION OF VIET NAM
|SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
|N0 21508/QLD-ĐK about guideline on applying ACTD dossier or ICH – CTD dossier
|Hanoi, December 19, 2017
To: Registration applicants of drugs for circulation in Vietnam
On November 25, 2014, Ministry of Health issued Circular No. 44/2014/TT-BYT on drug registration whereby at Point b Clause 8 Article 16 of Circular No. 44/2014/TT-BYT specified “In case new chemical drugs, vaccines, serum containing antibodies and medical biologicals can not be arranged according to the ACTD dossier, those may be arranged according to the Common Technical Document of The International Conference on Harmonization (ICH-CTD). This guideline has also been stipulated since 2009 at Point b, Clause 7, Article 17 of the Circular No. 22/2009/TT-BYT on drug registration dated November 24, 2009 by Ministry of Health.
However, due to the fact that some drug registration applicants do not fully understand the above regulations, the foreign drug registration applicants has revised the foreign registration dossiers which is approved in the host country from the ICH-CTD format to ACTD format when apply registration in Vietnam. This caused the difficult situation for businesses and is unnecessary.
In order to harmonize regulations on drug registration, Drug Administration of Vietnam hereby notifies that the drug registration applicants can submit the registration dossiers based on the ASEAN Common Technical Dossier (ACTD) or the Common Technical Document of The International Conference on Harmonization (ICH-CTD) when apply registration of drugs for circulation in Vietnam in accordance with the above Circular No. 44/2014/TT-BYT.
Drug administration of Vietnam notifies the facilities to know and comply with the current regulation on drug registration and circulation.
For General Director
Vice General Director
(Signed and Sealed)
Do Van Dong
The official letter 21508/QLD-ĐK about guideline on applying ACTD dossier or ICH – CTD dossier
COPY PLEASE TO REFER VNRAS.COM
44/2014/TT-BYT thông tư quy định việc đăng ký thuốc
Translated by Minh Van