The (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
- Enhanced independence of ethics committees and regulation of ethics review procedures
- Sites required to manage clinical studies properly
- Increased daily supervision by 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 (firstname.lastname@example.org or email@example.com). The Ropes & Gray LLP website can be accessed at www.ropesgray.com.