China Adopts Special Approval Procedure for New Drugs       

The State Food and Drug Administration (SFDA) has released the Administrative Provisions for the Special Examination and Approval of New Drug Registration which took effect on January 7th.
   The new rule is intended to encourage new drug development and boost risk control, a SFDA spokesman said. To reduce waiting approval time for such drugs, a special channel has been set up for them to go through the whole registration application process. The works will be done with a time limit according to the Drug Registration Regulation.
   Under the special approval procedure, the clinical test for a new drug must be completed within 80 days and the production permit for a new drug must be decided in 120 days. For other common drugs, it may take as long as 90 days for clinical tests and up to 150 days for production permit.
   New drugs that meet any one of the following four conditions can enjoy the special approval procedure.
   1. Effective ingredients and preparations derived from plants, animals and minerals as well as newly discovered medicinal materials and preparations, never marketed in domestic market;  
   2. Chemical pharmaceutical and preparations and biological products, never gained approval for sales in both home and abroad;
   3. New drugs with significant clinical curative effects in treating HIV/AIDS, cancers and orphan diseases;  
   4. New drugs for illness currently without other treatment methods.
   The revised Drug Registration Regulation has become effective since October 1st, 2007. To make it play a significant role, SFDA has planned to issue four complementary writs. On January 7th, 2008, it released the first one - the Supplementary Provisions for Traditional Chinese Medicine Registration, followed by the Provisions for on-site Examination in Drug Registration publicized in May 2008. The Administrative Provisions for the Special Examination and Approval of New Drug Registration above mentioned is the third one, and the last - the Provisions for Medication Technology Transfer Registration, will be announced and implemented in near future.