CFDA proposes updates to clinical practices

China FDA proposed revisions to its Good Clinical Practices for pharmaceuticals that would bring the country's policies closer in line with international standards, according to life sciences law firm Ropes & Gray. CFDA is accepting comments on the proposed changes through Jan 31, 2017.

The revisions would require clinical study sponsors to obtain informed consent before storing biological samples or using them for future studies, and bar investigators from performing testing unrelated to a study's protocol, Ropes said. The changes would require that trial monitors and auditors be given direct access to study documents and data, and that participants in blinded trials be informed of their treatment status once the study is completed, according to the firm. The revisions would prohibit asking trial subjects to waive legal rights; prohibit agreements that would release study sponsors, sites or investigators from liability; and require sponsors to insure investigators and study sites against all claims except malpractice...