CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
the 60-day period, which will be recalculated if supplementary documents are required. • If the CDE issues an objection, the sponsor may reply in writing concerning all issues raised by the CDE and reapply for approval of the clinical trial. The CDE will further review and determine whether to approve that clini- cal trial within 60 days of receiving the reap- plication, and the sponsor is only allowed to implement the clinical trial upon receipt of the CDE’s written approval. Clinical trial requirements for medical devices vary according to the relevant classification. Specifically, Class I medical devices are exempt- ed from clinical evaluations, while Class II and III medical devices may undergo clinical evalua- tions or clinical trials subject to their safety and effectiveness. • Clinical evaluation: unless otherwise exempt from a list issued by the NMPA, Class II and III medical devices are subject to clinical evaluation conducted by the NMPA. • Clinical trial: if the existing clinical literature and clinical data are insufficient to demon- strate the safety and effectiveness of a medi- cal device, a clinical trial should be imple- mented instead. The MDAL Draft proposes shortening the approval period for medical device clinical trials from 60 days to 30 days. 2.3 Public Availability of the Conduct of a Clinical Trial The Drug Clinical Trial Registration and Informa- tion Platform (www.chinadrugtrials.org.cn) host- ed by the NMPA is a public database providing detailed information regarding clinical trials of pharmaceuticals for the purpose of registration. The Specifications for Drug Clinical Trial Plan Submission and Review reiterate that an appli-
cant register the drug clinical trial plan on the platform prior to conducting a drug clinical trial. There is no publicly available database for clini- cal trials of medical devices in the PRC. 2.4 Restriction on Using Online Tools to Support Clinical Trials There are no specific restrictions on using online tools to support clinical trials. Using these tools is subject to generally applicable laws and regu- lations concerning personal information protec- tion, online advertising, etc. 2.5 Use of Data Resulting From Clinical Trials Raw data generated from clinical trials may include trial subjects’ personal information, health data, genetic resources, etc. The Personal Information Protection Law (the “PIPL” ) provides a legal framework for the admin- istration of handling personal information. During clinical trials, sites, principal investigators, spon- sor-designated monitors and other third parties may access trial subjects’ personal information. However, sponsors will generally only receive anonymised data from the trial. Moreover, the sharing and transferring of personal data is sub- ject to other statutory requirements, such as the receipt of data subjects’ consent, restrictions on cross-border data transfer, etc. In March 2024, the Cyberspace Administration of China issued the Provisions on Promoting and Regulating Cross-border Data Flow, which refines the spe- cific requirements for cross-border data transfer. Human genetic resource (HGR) samples and data are governed by the Biosecurity Law and the Administrative Regulation on Human Genetic Resources (the “HGR Regulation” ). Foreign par- ties are currently only permitted to use Chinese
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