CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
Evaluation of Adverse Event Relatedness in Drug Clinical Trials ( “Trial Implementation” ) to provide a reference for sponsors, investigators, regulato- ry agencies and other relevant personnel in con- ducting surveillance, identification, assessment and control of adverse reactions in drug clinical trials. For clinical trial institutions, the Measures for the Supervision and Inspection of Drug Clini- cal Trial Institutions ( “Trial” ) tailor the rules on supervising compliance with the GCP for drug trials and other relevant rules by the institutions in the process of filing and clinical trials. The Administrative Measures stipulate that pro- vincial medical products administration (MPA) may employ various inspections to supervise clinical trial institutions. The MPA will require those institutions found to be non-compliant to suspend any new clinical trials for drugs. Nota- bly, the NMPA issued new regulations in 2024 to optimise the review and approval procedures for clinical trials of innovative drugs, including reducing the standard review period to 30 days, and launched pilot programmes in Beijing and Shanghai. The Frequently Asked Questions on Rapid Reporting of Safety Data during Drug Clinical Tri- als was updated to version 2.0 in 2023, aiming to align with the relevant International Council for Harmonisation regulations. Likewise, the RSAMD and the Device Regis- tration Measures set out the legal framework on whether and how clinical trials of medical devices should be conducted, while an array of review standards and guidance, such as GCP for medical devices trials, further specify operation- al guidance and technical requirements for con- ducting clinical trials. For clinical trial institutions, in line with the regulatory approach for drug clini- cal trials, the NMPA issued regulations on the
supervision and inspection of medical device clinical trial institutions in June 2024. For clini- cal trials for IVD reagents, the NMPA provides special principles with a separate guideline. The Trial Measures for the Review of Sci-tech Ethics Clinical requires that entities engaged in the life sciences, medicine and other scitech activities set up a scitech ethics review commit- tee to assess the scitech 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 Procedure for 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 authorised by the CDE of the NMPA 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-con- sultation 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 days of acceptance of the clinical trial application. For pilot projects that meet the requirements, the CDE will complete the review and approval process within 30 days after receiving the application and will notify the applicants of the approval or rejec- tion decision through its website. Applicants must wait for this notification before proceed- ing with subsequent work. • If there is no objection from the CDE, the sponsor may implement the clinical trial after
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