CHINA Trends and Developments Contributed by: Min Zhu, Ya-ling (Michelle) Gon, Yang (Aaron) Gu, Chai Lu, Ying Li and Shiye Yuan, Han Kun Law Offices
specify the co-ordination action between SAMR and other authorities. In January 2025, the SAMR issued the Compliance Guidelines for Pharmaceutical Enterprises to Pre- vent Commercial Bribery Risks , which constitutes an important step in shifting the regulation of com- mercial bribery in the pharmaceutical industry from enforcement to prevention. The guidelines system- atically consolidate and analyse commercial bribery risk points across nine specific scenarios covering the full pharmaceutical procurement and sales process – including academic visits and exchanges, business hospitality, consultancy services and outsourcing services – and provide scenario-specific, risk-tiered guidance highlighting both compliant practices to be observed and prohibited conduct to be avoided. In addition to the overview of key regulatory updates above, the following discuss regulatory highlights for drugs and medical devices, respectively. Drug highlights On 19 March 2025, the Comprehensive Department of the National Medical Products Administration (NMPA) released the Measures for the Implementation of Drug Regulatory Data Protection (Trial, Draft for Comments) and the Procedures for Drug Regulatory Data Pro- tection (Draft for Comments) , which aim to provide detailed implementation guidance for the current drug regulatory data protection system. The drafts stipulate that the NMPA shall provide a protection period of six years, three years or other varying durations for trial data and other data submitted by the applicants that were independently obtained and not publicly disclosed at the time of marketing approval for new chemical entities or other pharmaceuticals specified in the drafts. The release of the drafts signals that China is steadily establishing a more systematic framework for the protection of pharmaceutical innovation. In September 2025, the NMPA released the Compli- ance Guidelines for the Online Retail of Prescription Drugs (Draft for Comments) , which is intended to ensure the quality and safety of drugs in online retail channels. The draft stipulates that online drug retail enterprises should appoint qualified pharmacists or other pharmaceutical professionals, and regulates
the presentation of prescription drug information from multiple perspectives, including requirements to prominently display risk warning information and to clearly distinguish between prescription and over-the- counter drugs. Towards the end of 2025, the NMPA released the Pro- visions on Administration of the Filing of Internet Infor- mation Services for Drugs and Medical Devices , which further implements and refines the requirements relat- ed to the transition from an approval-based system to a filing-based system, including clarifying the qualifi- cations of filing entities and specifying the required filing materials. The provisions also stipulate that drug regulatory authorities will leverage information tech- nology, digital tools and intelligent methods to con- duct online monitoring of drug and medical device information published on websites, client applications and mobile applications that provide internet informa- tion services for drugs and medical devices. Medical device highlights In November 2025, the NMPA revised the Good Man- ufacturing Practice for Medical Devices (the “Medical Device GMP”), which emphasises that enterprises should integrate risk management principles through- out the entire operation of their quality management systems. The revised Medical Device GMP also intro- duces three new chapters: quality assurance, verifica- tion and validation, and contract manufacturing and outsourced processing, reflecting the strengthened regulatory focus on life cycle quality management across the medical device manufacturing process. In April 2025, the NMPA released the Good Supply Practice for Network Sales of Medical Devices , which sets forth clear requirements for operators engaged in the online sale of medical devices and e-commerce platforms providing services for online medical device transactions, including the establishment of qual- ity management systems tailored to online medical device sales and the fulfilment of obligations related to information displays. Building on this document, the NMPA further issued the Guiding Principles for On-site Inspection of Good Supply Practice for Network Sales of Medical Devices in September 2025, which aims to standardise and guide on-site inspections of online medical device sales activities.
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