The China Food and Drug Administration (CFDA) has released for public comment proposed revisions to the good clinical practice (GCP) rules for pharmaceutical clinical studies. The proposed revisions, if eventually promulgated, will be the first revision since the enactment of the existing GCP rules in September 2003.
Without changing the structure of the existing GCP rules, the revisions introduce specific responsibilities for sponsors, ethics committees and sites, with the aim of enhancing protection of study subjects. They also require local food and drug administrations to be more involved in the day-to-day supervision of clinical studies. Highlights of the revisions are as follows.
Increased responsibilities for sponsors
Under the revised GCP rules, sponsors will continue to be permitted to outsource certain tasks in clinical studies to third parties (eg, contract research organisations), provided that such third parties' responsibilities are clearly documented in relevant contracts. Sponsors must evaluate and inspect such third parties and be ultimately responsible for the quality of their work. Concerning the administration of study drugs, the revised GCP rules require sponsors of bioavailability and bioequivalence studies to retain sufficient samples from the same batch of study drugs for at least two years after receiving marketing authorisation. The proposed revisions also clarify that sponsors are responsible for continuously evaluating the risks and benefits of study drugs – including analysing any safety-related information that they receive – and promptly reporting any suspected or unexpected serious adverse reaction to government authorities.
Enhanced independence of ethics committees and regulation of ethics review procedures
The proposed revisions require ethics committees to be independent and disclose their charters and procedures to the public. Each member of an ethics committee must disclose any potential conflict of interest. Ethics reviews can be initiated before the CFDA's issuance of clinical trial authorisations. Ethics committees must review and approve all written documents to be provided to subjects (eg, consent forms and recruiting materials), in addition to the clinical study protocols. Ethics committees must also review:
- any serious adverse event or any other event or new information that may change the risk/benefit analysis;
- the reasons for any early termination of clinical studies;
- follow-up studies on subjects; and
- the completion of clinical studies.
Ethics committees must periodically evaluate subjects' risks and benefits at least once a year.
Sites required to manage clinical studies properly
Sites conducting clinical studies must have appropriate management systems and qualified personnel to manage clinical studies properly. They must closely collaborate with sponsors and investigators. All three parties must communicate among themselves and with government authorities regarding any suspension, termination or potential issues of the clinical studies.
Increased daily supervision by provincial food and drug administrations
Provincial food and drug administrations will undertake a more important role in the daily supervision of clinical studies under the proposed revisions. Each ethics committee and each site must report annually to their respective provincial food and drug administration regarding the clinical studies that they review or manage. In addition, sponsors and investigators must promptly report any serious adverse event to provincial food and drug administrations.
For further information on this topic please contact Katherine Wang or Mark Barnes at Ropes & Gray LLP by telephone (+86 21 6157 5200) or email (k[email protected] or m[email protected]). The Ropes & Gray LLP website can be accessed at www.ropesgray.com.
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