CFDA releases 2018 legislative plan

China FDA published a legislative road map for 2018 that outlines the agency’s plans to revise drug laws and regulations as well as develop guidance documents.

Among the legislative projects in the 2018 plan, CFDA proposes to make amendments to the country's drug administration law and to review laws concerning drug patents. The road map includes plans for draft or revised guidance for good clinical practices as well as the registration of medical devices and in vitro diagnostics. It also includes plans to develop and revise regulations covering medical device supervision, cosmetics supervision and food safety.

The road map follows a series of new guidelines and reforms the agency has issued in the past year aimed at modernizing its policies and improving transparency. In October, CFDA implemented reforms to modernize rules governing multicenter clinical trials and the drug registration and approval process, following a broad policy directive issued by the country's State Council laying out guidelines for reforms (see BioCentury Extra, Oct. 10, 2017).

Additional recent reforms include draft guidelines for a conditional approval pathway, development of cell therapy products, and public disclosure of information regarding drug applications to improve transparency. At the WuXi Global Forum in January, CFDA Chief Scientist Ruyi He said the agency has made a push to increase efficiency, innovation and transparency (see BioCentury Extra Jan. 10 & Jan. 19).

The regulatory reforms are intended to catalyze development of innovative pharmaceuticals by domestic companies and bring the agency's policies closer in line with Western standards. To that end, CFDA became a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) last June (see BioCentury, Dec. 1, 2017).