China promotes Good Laboratory Practice certification for non-clinical drug research

2008-07-18 02:07:20 GMT       2008-07-18 10:07:20 (Beijing Time)       Xinhua English

BEIJING, July 18 (Xinhua) -- China promotes Good Laboratory Practice (GLP) certification for non-clinical drug research, says a white paper published by the Information Office of the State Council on Friday.

China practices a certification system for the quality control over drug research, manufacturing and distribution, aiming to tighten drug safety control in an all-round way, states the white paper.

To improve the quality of non-clinical drug research and ensure the authenticity, integrity and reliability of experimental data, China promulgated the GLP for Non-clinical Laboratory Studies in 1999, and began the work of GLP certification in April 2007, the paper says.

So far, a total of 27 non-clinical drug research institutions have obtained GLP certification, says the paper.

Starting from January 1, 2007, all non-clinical drug safety research must be carried out in GLP-certified laboratories in the case of the evaluation of new drugs, which include chemical drug substances and their preparations, and biological products not yet marketed in China; effective components and organs extracted from plants, animals and minerals as well as their preparations not yet sold on the domestic market; effective components extracted from traditional Chinese medicine (TCM) and natural medicines as well as their preparations, and TCM injections, says the paper.

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