9 Sep 2009 11:23

SFDA approves production of 1,700 drugs in H1

Shanghai. September 9. INTERFAX-CHINA - China's State Food and Drug Administration (SFDA) approved the production of 1,700 drugs in the first six months of this year, the SFDA announced on Sept. 8.

The SFDA approved applications for the production of 238 new drugs, 1,074 generic drugs and 388 imported drugs.

Eight new class one drugs were approved, including antofloxacin hydrochloride tablets, and meningococcal group A and C bivalent polysaccharide conjugate vaccine.

In addition, the SFDA approved 173 clinical trial applications, including those for lamivudine and combination nevirapine, zidovudine and lamivudine, which are used to treat AIDS, and donepezil hydrochloride tablet, which is used to treat Alzheimer's disease.

To speed up the marketing of anti-tumor drugs in China, the SFDA exempted manufacturers from conducting clinical trials of sorafenib, sunitinib malate capsule, and decitabine injection, but asked producers to conduct post marketing clinical trials.

According to figures from the SFDA, from Oct. 1, 2007 to June 2009, the SFDA received 4,403 applications for clinical trial and drug production approval. In 2005 alone, the SFDA approved 11,086 such applications.

"The number of applications shows a declining trend, with present annual applications dropping by two-thirds from a few years ago," Zhang Wei, chief of the drug registration division of the SFDA told a press conference in Beijing on Sept. 8.

The ratio between a drug and the number of applicants declined from 1:6 in 2006 to 1:3 this year, and so far this year, no traditional Chinese medicine manufacturers applied for approval of the same medicine as a competitor.

"The reduced number of drug production and clinical trial applications also reflects a rise in the percentage of new drugs and that China's drug registration process is on the right track," Zhang said.