China Releases Draft Revised Pharmaceutical Good Clinical Practices

The China Food and Drug Administration (CFDA) has announced draft revisions to its pharmaceutical Good Clinical Practices (GCP) . The revisions will add additional responsibilities and requirements to the current GCP regulations, which were enacted in September 2003. The new regulations are roughly similar to the International Conference on Harmonization (ICH) guidelines, so Western companies should not be significantly affected by the changes.

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