Notice on Dossier Requirements of Chemical Drug Registration Classification (trial implementation) CFDA Order No.80 2016

In order to carry out the requirements of Chemical Drug Registration classification work program, and standardize the registration, China Food and Drug Administration (CFDA) reformed Dossier Requirements of Chemical Drug Registration classification (trial implementation), which are hereby promulgated, and shall come into force as from the date of announcement.

Hereby notify the above.

CFDA

May 4, 2016

Dossier Requirements of Chemical Drug Registration classification (trial implementation) (see annex)

http://www.sda.gov.cn/WS01/CL0087/151985.html