BRIEF—China call for generics; NMPA draft

China's national health commission has issued a list of 34 drugs for which it urges generics from Chinese companies.

This is the first batch of such list. Many of the listed drugs are treatments for cancers, AIDS and rare diseases, including bosentan, deferasirox, rilpivirine and ixabepilone, all of which currently see no generics in China.

However, bosentan, marketed by Actelion/Johnson & Johnson as Tracleer, has already attracted abbreviated new drug applications (ANDAs) from several Chinese companies including Chongqing-based Huapont and Beijing-based Wansheng.

Draft amendment on drug regulation

China’s National Medical Products Administration (NMPA) has issued a draft of the amended drug registration regulation for public opinion until October 30.

One major change is it added four fast approval approaches, including breakthrough therapy, priority review, special approval and conditional approval.

Drugs in shortage, pediatric medicines, drugs for rare diseases, vaccines in need, novel vaccines and drugs for highly infectious diseases will enjoy the fast approval processes.