CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
2. Clinical Trials 2.1 Regulation of Clinical Trials
1.2 Challenging Decisions of Regulatory Bodies The decisions of the regulatory bodies that apply and enforce pharmaceuticals and medical devices regu- lations can be challenged through an administrative review or administrative litigation. These procedures also apply in general vis-à-vis administrative regula- tory bodies for other regulated products. Administrative review is a procedure for challenging regulatory body decisions. If the decisions made by the reviewing body are unacceptable, a lawsuit before the court could be filed, unless the administrative review decisions are final as prescribed by law. Alter- natively, proceedings may be instituted directly with a court, except in certain circumstances in which an administrative review must first be applied for. Once the court accepts the case, no further administrative review can be sought. 1.3 Categories of Pharmaceuticals and The DAL classifies drugs as prescription drugs and non-prescription (over-the-counter or OTC) drugs under different supervision requirements. A patient must present prescriptions when purchasing prescrip- tion drugs, while OTC drugs can be bought without prescriptions. China further subdivides OTC drugs into Class A and Class B, according to their safety level. Marketing authorisation holders (MAHs) may apply for the conversion of prescription drugs to OTC drugs and vice versa, which shall be subject to the final decision of the NMPA. Medical Devices The RSAMD classifies medical devices into three classes according to their risk levels and expected purposes, structural features, methods of use and other qualities. Class III medical devices have the highest risk level and their safety and effectiveness should be ensured through strict controls. Medical Devices Pharmaceuticals
The DAL and the Administrative Measures for Drug Registration establish the primary principles and statutory requirements for clinical trials. Guidance and technical review standards issued by the NMPA and the Centre for Drug Evaluation (CDE), NMPA – such as the Good Clinical Practice (GCP) for Drug Trials and Guidelines for Clinical Trials of Therapeutic Drugs for Depressive Disorders (Trial) – provide guid- ance detailing the obligations of the parties involved, operational procedures, technical requirements, etc. In June 2024, the CDE released the Technical Guide- lines for the Evaluation of Adverse Event Relatedness in Drug Clinical Trials to provide a reference for spon- sors, investigators, regulatory agencies and other relevant personnel in conducting surveillance, identi- fication and assessment of adverse reactions in drug clinical trials. For clinical trial institutions, the Measures for the Supervision and Inspection of Drug Clinical Trial Insti- tutions 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. For investigator-initiated clinical studies conducted by medical and health institutions that are not for the purpose of product registration, the Administrative Measures for Investigator-Initiated Clinical Studies Conducted by Medical and Health Institutions shall apply. The Administrative Measures for Drug Registration stipulate that provincial medical products administra- tion (MPA) may employ various inspections to super- vise clinical trial institutions. The MPA will require those institutions found to be non-compliant to suspend or terminate any new clinical trials for drugs. Notably, the NMPA issued new regulations in 2025 to optimise the review and approval procedures for clinical trials of innovative drugs, including reducing the standard review period to 30 working days. Likewise, the RSAMD and the Device Registration Measures set out the legal framework on whether and how clinical trials of medical devices should be con- ducted, while an array of review standards and guid-
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