New Chinese GLP and GCP standards

China's State Drug Administration has issued new Good LaboratoryPractice and Good Clinical Practice regulations, reports Chinese Medical News.

The new GLP regulations were developed on the basis of internationally-recognized principles, with adaptation to the current situation in China. The SDA hopes to accelerate the internationalization of drug research in China with these new rules. It will also publish guidance on implementation, certification standards and training manuals as the plan rolls out.

To implement the new GCP regulations, the SDA will: evaluate drug clinical research centers; set up and supervise a GCP regulation system; expand the implementation of GCP standards, so that the clinical trials of Class I and II drugs can be carried out in GCP standard institutions; draft GCP certification standards; and organize GCP training.