CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
ance, such as GCP for medical devices trials, further specify operational guidance and technical require- ments for conducting clinical trials. For clinical trial institutions, in line with the regulatory approach for drug clinical trials, the NMPA issued regulations on the supervision and inspection of medical device clinical trial institutions in June 2024. For clinical trials for IVD reagents, the NMPA provides special principles with a separate guideline. The Trial Measures for the Review of Sci-tech Ethics require that entities engaged in the life sciences, medi- cine and other sci-tech activities set up a sci-tech ethics review committee to assess the sci-tech ethics risks, conduct an ethical review, etc. As such, clinical trials for drugs and medical devices must comply with the relevant ethical review requirements. 2.2 Securing Authorisation to Undertake a Clinical Trial Clinical trials for drugs are generally required before the sponsor applies for marketing authorisations, unless otherwise exempted by law (such as certain generic drugs and IVD). A clinical trial must be author- ised by the CDE before its implementation. The gen- eral steps for securing pharmaceutical clinical trial authorisation are as follows. • A review by an ethical committee prior to initiation. • A sponsor may need to apply for a pre-consultation meeting with the NMPA. • The sponsor may conduct a clinical trial if it has not received any objection or query from the CDE within 60 working days of acceptance of the clini- cal trial application. • For innovative drugs clinical trial that meet the requirements, the CDE will complete the review and approval process within 30 working days after receiving the application and will notify the appli- cants of the approval or rejection decision through its website. • Applicants must wait for this notification before proceeding with subsequent work. • If there is no objection from the CDE, the sponsor may implement the clinical trial after the aforemen- tioned period, which will be recalculated if supple- mentary documents are required.
• If the CDE issues an objection, the sponsor may reply in writing concerning all issues raised by the CDE and re-apply for approval of the clinical trial. The CDE will further review and determine whether to approve that clinical trial within 60 days of receiving the re-application, 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 exempted from clinical evaluations, while Class II and III medical devices may undergo clinical evaluations 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 conduct- ed by the NMPA. • Clinical trial: if the existing clinical literature and clinical data are insufficient to demonstrate the safety and effectiveness of a medical device, a clinical trial should be implemented instead. The MDAL Draft proposes shortening the approval period for medical device clinical trials from 60 working days to 30 working days. 2.3 Public Availability of the Conduct of a Clinical Trial The Drug Clinical Trial Registration and Information Disclosure Platform (www.chinadrugtrials.org.cn ) hosted by the CDE is a public database that provides detailed information regarding clinical trials of phar- maceuticals for the purpose of registration. The Speci- fications for Drug Clinical Trial Plan Submission and Review reiterate that an applicant must register the drug clinical trial plan on the platform prior to conduct- ing a drug clinical trial. There is no publicly available database for clinical tri- als of medical devices in the PRC. 2.4 Use of 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 regulations concerning
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