China: CDE clears up clinical trial safety data confusion in new FAQ document

17-04-2019

China: CDE clears up clinical trial safety data confusion in new FAQ document

(Source: RAPS 2019-04-18)

China’s Center for Drug Evaluation (CDE) has sought to clarify its clinical trial adverse event reporting requirements in a frequently asked question (FAQ) document. The text addresses areas of confusion that have arisen since the introduction of guidance on the topic one year ago.

CDE’s FAQ starts out clarifying basic points about the scope of adverse event reporting rules, such as whether the requirements apply to clinical trials of vaccines. Having clarified that sponsors of vaccine clinical trials must comply with the reporting rules, CDE goes on to address more specific questions about the application of the requirements to certain circumstances.

Specific questions include how companies that are yet to create pharmacovigilance systems capable of submitting reports in either of the requested formats can comply with the requirements. CDE is advising companies in this situation to outsource the work.

Another section of the FAQ deals with the division of responsibilities when reporting is outsourced to a contract research organization (CRO). The CRO can help with the submission of case reports, but the sponsor retains ultimate responsibility.

CDE plans to update the document as new issues arise.

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