CNDA seeks feedback on latest GCP Regulation Draft

The Chinese National Drug Administration (CNDA) is looking for feedback by August 16, 2018

The China National Drug Administration released a major draft amendment to the national drug Good Clinical Practice (GCP) guideline, opening a window for public feedback running from July 17 to August 16, 2018.

The proposed amendments follow a previous draft and feedback process that was started in December 2016.

Key changes include clarification on clinical trial applicant’s responsibilities, setting out terms for applicants to establish a quality management system, setting up an independent data monitoring committee, applying risk-based monitoring techniques, while maintaining the primacy of subjects’ rights and safety.

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