CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The primary statute regulating pharmaceuticals in the People’s Republic of China (PRC) is the Drug Admin- istration Law (DAL). Together with its implementing rules – newly revised and due to enter into force on 15 May 2026 (the “Revised Implementing Rules”) – the DAL governs various drug-related activities, including drug development, registration, manufacturing, distri- bution and use. In order to address statutory requirements under the DAL, good practice (GxP) rules on laboratory, clinical trials, manufacturing, distribution and pharmacovigi- lance have also been enacted, as well as adminis- trative measures on drug registration, manufacturing, distribution and recall, etc. Product-specific laws, rules and guidelines – such as the Vaccine Adminis- tration 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 comment on 28 August 2024. The MDAL Draft introduces chapters related to medical device standards and classification, R&D, importation and exportation, and use to empha- sise the life cycle management of medical devices. It is noteworthy that the content of the MDAL Draft is subject to further revision and review, and, upon the official release of the final document, the Medical Devices Administration Law (MDAL) will be the first basic law in the PRC to regulate medical devices, with its legal hierarchy being higher than the effective Regulations for the Supervision and Administration of Medical Devices (RSAMD). The development, regis- tration/filing, manufacturing, distribution and use of medical devices are, like pharmaceuticals, 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 Devices (the “Device Registration Measures”) and the Administra- tive Measures on the Registration and Record-filing of In Vitro Diagnosis (IVD) Reagents were released to update and specify the regulatory procedure and
requirements for medical device and IVD reagent reg- istration and filing, respectively. Regulatory Bodies State Administration for Market Regulation (SAMR) The SAMR is the national authority for the market supervision, administration and law enforcement of pharmaceuticals and medical devices, in the areas of anti-monopoly, product quality safety, fair competi- tion and commercial bribery, the issuance of business registrations, and certifications and accreditations, among others. National Medical Products Administration (NMPA) As a national bureau operating under the supervi- sion of the SAMR, the NMPA regulates the registra- tion, post-market risk management, administration of safety and quality, formulation of industrial/national standards, and supervision and inspection of phar- maceuticals and medical devices. The NMPA also supervises permit/filing receipt issu- ance and law enforcement on pharmaceuticals and medical devices on the provincial level, while the local administrations for market regulation (AMR) are in charge of certain permit issuance and law enforce- ment on pharmaceuticals and medical devices at city and county levels. National Health Commission (NHC) The NHC is mainly responsible for national health poli- cies, reform of the medical and healthcare system, disease prevention and control, national drug policies and the national basic drug system. It supervises the National Administration of Traditional Chinese Medi- cine and the National Disease Control and Preven- tion Administration. It is also responsible for human generic resource (HGR) management. National Healthcare Security Administration (NHSA) The NHSA is mainly responsible for the preparation and implementation of regulations and policies related to basic medical insurance (BMI), including policies regarding reimbursement, pricing and procurement for pharmaceuticals and medical services.
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