CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations A drug MAH (and its local MAH deputy, if it is an overseas MAH) has the following post-marketing obligations under the DAL and relevant regula- tions: • implementing a pharmacovigilance system; • conducting regular post-market launch appraisals; • establishing a release process for drug mar- ket launches; • establishing and implementing a drug-track- ing system; and • establishing an annual report system. The NMPA has promulgated Guidelines on Phar- macovigilance Inspections and Good Practice for Pharmacovigilance Systems to guide a drug MAH in establishing a pharmacovigilance sys- tem. To refine the quality and safety management throughout the entire drug life cycle and clarify the key responsibilities of a MAH, the NMPA subsequently issued Provisions on the Super- vision and Administration of Drug Marketing Authorisation Holder Implementation of the Main Responsibility of Drug Quality and Safety in 2023 to summarise relevant provisions previ- ously scattered across the DAL and other laws and regulations. A medical device MAH is also responsible for post-marketing obligations, including: • establishing and maintaining a quality man- agement system; • setting up and implementing the post-mar- keting research and risk management and control plan;
patients access to pre-approval, investigational drugs if the drug: • is in a clinical trial; • is used for diseases that threaten life but lack effective treatment; • has potential effectiveness based on medical observations; • usage complies with ethical principles; • usage has been reviewed and the patient’s informed consent has been obtained; and • is only used within the clinical trial site and is used on patients outside the clinical trial set- ting but with similar conditions. In addition to these requirements under the DAL, certain regions have introduced regional rules for expanded access programmes. Both Tianjin and Shenzhen have issued Regulations on the Promotion of Cell and Gene Industries, which permit expanded access programmes regarding cell and genetic drugs held in Tianjin and Shenz- hen Special Economic Zone on certain grounds, such as approval for expanded clinical trials and submission of the marketing authorisation appli- cation to the CDE for these drugs. The RSAMD also has similar requirements for an expanded access programme for investigational medical devices. Moreover, the Regulations for the Emergency Use of Medical Devices specify an emergency use system that permits the use of medical devices without marketing authori- sations in public health emergencies, including implementing authorities and their responsibili- ties, detailed procedures for expert verification, etc.
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