China FDA draft GCP guidelines in line with harmonization aims

SINGAPORE--China FDA has issued draft guidelines on changes to good clinical practice guidelines that cover 34 provisions, including the use of outsourced partners in China, that are generally in line with international aims of harmonization, according to analysts.

Comments on the draft, issued in the Chinese language, are due by Feb. 28.

Contract research organizations and multinational companies in China have been expecting new guidelines for the past year to determine to what extent the CFDA wants to require oversight of more complex trials.

As well, companies were keen to know the extent to which the regulator would continue to use the touchstone of International Conference on Harmonization practices for any guidelines.

The draft refines reporting, safety evaluations and mandates how ethical committees should handle responsibilities, according to a translation.

China reorganized the FDA last year as part of a sweeping safety push across drugs, food and medical devices and the safety of patients in clinical trials.

Multinational drugmakers however have said the reorganization has not led to faster evaluation on drug approvals as of yet. Concern is also growing that China may move to restrict the use of multiregional clinical trials in approvals.

- view the draft (Chinese)