CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices The primary statute regulating pharmaceuticals in the People’s Republic of China (the “PRC” ) is the Drug Administration Law (the “DAL” ). Together with its implementing rules, the DAL governs various drug-related activities, including drug development, registration, manufacturing and distribution. In order to address statutory requirements under the DAL, good practice (GxP) rules on labora- tory, clinical trials, manufacturing, distribution and pharmacovigilance have also been enacted, as well as administrative measures on drug reg- istration, manufacturing, distribution and recall, etc. Product-specific laws, rules and guidelines, such as the Vaccine Administration Law and the Administrative Measures on Blood Products, also apply to the respective products. The draft Medical Devices Administration Law (the “MDAL Draft” ) was released for public com- ment on 28 August 2024. The MDAL Draft intro- duces chapters related to medical device stand- ards and classification, R&D, import and export and use to emphasise the life cycle management of medical devices. It is noteworthy that the con- tent of the MDAL Draft is subject to further revi- sions and reviews and upon the official release of the final document, the Medical Devices Admin- istration Law (the “MDAL” ) will be the first basic law in the PRC to regulate medical devices, with its legal hierarchy higher than the effective Regu- lations for the Supervision and Administration of Medical Devices (the “RSAMD” ). The develop- ment, registration/filing, manufacturing and dis- tribution of medical devices are, like pharmaceu- ticals, regulated by GxP rules and administrative
measures. Product-specific rules and guidelines have also been released and implemented. Furthermore, the Administrative Measures on the Registration and Record-filing of Medical Devic- es (the “Device Registration Measures” ) and the Administrative Measures on the Registration and Record-filing of In Vitro Diagnosis (IVD) Reagents were released to update and specify the regu- latory procedure and requirements for medical device and IVD reagent registration and filing, respectively. Regulatory Bodies State Administration for Market Regulation (SAMR) The SAMR is the national authority for the mar- ket supervision, administration and law enforce- ment of pharmaceuticals and medical devices, in the areas of anti-monopoly, product quality safety, food safety, fair competition and com- mercial bribery, the issuance of business reg- istrations, and certifications and accreditations, among others. National Medical Products Administration (NMPA) As a national bureau operating under the super- vision of the SAMR, the NMPA regulates the registration, post-market risk management, administration of safety and quality, formulation of industrial/national standards, and supervision and inspection of pharmaceuticals and medical devices. The NMPA also supervises permit/filing receipt issuance and law enforcement on pharmaceuti- cals and medical devices on the provincial level, while the local administrations for market regula- tion (the “AMR” ) are in charge of certain permit issuance and law enforcement on pharmaceu-
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