New SFDA lab regulations raise testing standards in China

Global Pharmatech, a China-headquartered firm specializing in the development, manufacture and marketing of drugs based on traditional Chinese medicine, has welcomed the announcement by the country's State Food and Drug Administration of regulations on the preclinical development of new drugs. The new rules came into effect on January 1 and require all pharmacology and toxicology studies in China for candidate drugs to be conducted in Good Laboratory Practice-certified laboratories.

Global Pharmatech claims that there are only 22 GLP-standard laboratories in China, and one of these, Jilin Tian Yao Drug Safety Evaluation Co (JDE), is a 99.5%-owned subsidiary of the firm. JDE is also one of only two privately-owned laboratories that meet the SFDA's new standards and has provided, since 2003, toxicology research services for local and international drugmakers.

Lianqin Qu, chief executive of Global Pharmatech, said: "we believe that implementation of this new policy will give us more opportunities to participate in the development of new drug products in China."