CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
ticals and medical devices at city and county levels. National Health Commission (NHC) The NHC is mainly responsible for national health policies, reform of the medical and healthcare system, disease prevention and control, national drug policies and the national basic drug sys- tem. It supervises the National Administration of Traditional Chinese Medicine and the National Disease Control and Prevention Administration. National Healthcare Security Administration (NHSA) The NHSA is mainly responsible for the prepara- tion and implementation of regulations and poli- cies related to basic medical insurance (BMI), including policies regarding reimbursement, pricing and procurement for pharmaceuticals and medical services. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation The decisions of the regulatory bodies that apply and enforce pharmaceuticals and medical devices regulations can be challenged through an administrative review or administrative litiga- tion. These procedures also apply in general vis- à-vis administrative regulatory bodies for other regulated products. Administrative review is a procedure to chal- lenge 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. Alternatively, proceedings may be instituted directly with a court, except in certain circumstances in which an administra- tive review must first be applied for. Once the
court accepts the case, no further administrative review can be sought. 1.3 Different Categories of Pharmaceuticals and Medical Devices Pharmaceuticals 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 pur- chasing prescription 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. Medical Devices The RSAMD classifies medical devices into three classes according to their risk levels and expect- ed 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. The DAL and the Administrative Measures for Drug Registration establish the primary princi- ples and statutory requirements for clinical trials. Guidance and technical review standards such as the Good Clinical Practice (GCP) for Drug Tri- als and the Pharmaceutical Research Informa- tion Guide for Phase III Clinical Trials of Innova- tive Drugs (Chemical Drugs) provide guidance detailing the obligations of the parties involved, operational procedures, technical requirements, etc. In June 2024, the Centre for Drug Evaluation (the “CDE” ) released the Technical Guidelines for the 2. Clinical Trials 2.1 Regulation of Clinical Trials
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