Drug registration Status in the first half of 2009 in China

This report has been released at 63^rd API China & INTERPHEX China Conference Program (November 2009).

In the first half of 2009 a total of 2983 types of drug approval documents was approved by the Food and Drug Administration of State, including the following: imported drugs 585, new Chemical Drugs 251, new Chinese Medicines 778, new biological drugs 24, strypped-down types including: 802 chemicals Approval,522 traditional Chinese medicine Approval, biological drug approval 20.

In the new chemical drugs, compared with last year, the approved drugs for the protection period, the transition period, approval and monitoring significantly reduced, only one species has a protection period, four with the transition period, 18 with monitoring period. Rabeprazole sodium enteric-coated tablets which are manufactured by Eisai (China) Pharmaceutical Co., Ltd. have a one-year protection period. Three agents and a variety of API with a transition period are oxybutynin hydrochloride sustained-release capsules from Shanghai Aidefa Pharmaceutical Co., Ltd., oral polyethylene glycol electrolyte solution from Beijing Sheng Yong Pharmaceutical Co., Ltd., 

Ibutilide Fumarate Injection from Zhejiang Jiuxu Medicine Co., Ltd. and pharmaceutical raw materials Ibutilide Fumarate from Zhejiang Jiuxu Pharmaceutical Co., Ltd.

In the New chemical drugs, there a total of 58 bulk drug approvals, 50 species, distributed into 15 major classes.  In the anti-infective classes, cardiovascular system and neuro system drugs continued to hold on the first 3, accounting for 50% of the total number of species, anticancer drugs, digestive system and its auxiliary substances and narcotic drugs are also the hot favorites, a total of eight varieties accounted for 16%.

In the 585 approvals for the imported drugs,there are 91 for supplementary orders, 494 are drug authorization approvals. Which include biopharmaceuticals 47, herbal 7, chemicals 440. Although China has now become the world's largest raw material medicine producer and exporter, but the multinational pharmaceutical companies in China have also imported a lot of APIs every year. In the first half of this year, there were 110 bulk drugs for import Approvals and 34 medicinal excipients approvals, API import approvals accounted for 25% and the accessories accounted for 7.7%.