China FDA Updates GCP Clinical Guidance - publishes Reg No. 25

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China FDA ( CFDA ) has published Reg No. 25 “Good Clinical Practice (GCP) on Mar 23, 2016. This came into effect on Apr 1, 2016 and replaces the old clinical study requirement Reg No. 5 published back in 2004.

The new GCP sets more detailed and strict requirements to many aspects of clinical study, including study preparation; patient welfare protection; required contents in the study protocol;   management of test devices and documentation, reporting and records.   The Regulation also explicitly defines respective responsibilities of ethics committee; sponsor and investigators. In many ways the new GCP is following the principles in ISO 14155.

Six affiliated documents have also been published:

  1. Ethics committee application form
  2. Patient consent letter
  3. Case Report Form ( CRF )
  4. Clinical study protocol template
  5. Clinical study report template
  6. List of documents to be archived.

Regulation 25 is lenghty and detailed and we will be publishing a deeper analysis of the new regulation in a later article.  But meanwhile in summary some of the main differences in the 2016 compared to the 2004 revision are:

  1. The concept of “Clinical trial” and “Clinical verification” had been removed in new GCP, by using the common terminology “ Clinical study”
  2. Devices used in trial must now be produced under the qualified quality management system.
  3. Patient welfare protection requirements have been substantially strengthened.
  4. The concept and requirements of Multi-center studies are now defined.
  5. There are stronger documentation management requirements.

In combination with the requirements for many more local clinical trials required to be performed in China, this substantial strengthening of GCP means it’s more important than ever to get things right.  Doing otherwise risks expensive failure if data are found not to be acceptable to CFDA.


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