China Releases Draft Revised Pharmaceutical Good Clinical Practices

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    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.

    If clinical trial sponsors use the services of a contract research organization (CRO) or other third party, the sponsor remains fully responsible for the quality of the clinical research. Sponsors must inspect and evaluate the third party organization and should continuously evaluate the benefits and risks of continuing the clinical study. Sponsors of bioavailability and bioequivalence studies will also be required to keep samples from the batches of drugs used in the study. Clinical trial sites must be managed by qualified personnel and must utilize appropriate management systems. All of these changes could make Chinese clinical trials more expensive to conduct.

    The GCP revisions further require provincial governments to take on a larger role in the supervision of clinical trials. The changes also include additional regulations and procedures for ethics committees to further ensure their independence and involvement with clinical trials. Ethics committee applications may be submitted at the same time as clinical trial authorizations, potentially reducing the time necessary to receive clinical trial approval.

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