CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
In addition to these requirements under the DAL, cer- tain regions have introduced regional rules for expand- ed 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 Shenzhen Special Economic Zone on cer- tain grounds, such as approval for expanded clinical trials and submission of the marketing authorisation application to the CDE for these drugs. The RSAMD also has similar requirements for an expanded access programme for investigational medical devices. More- over, the Regulations for the Emergency Use of Medi- cal Devices specify an emergency use system that permits the use of medical devices without marketing authorisations in public health emergencies, includ- ing implementing authorities and their responsibilities, detailed procedures for expert verification, etc. Moreover, for pharmaceuticals and medical devices not yet marketed in China but in clinical urgent need, relevant work plans for temporary importation have been issued at the national and local levels to improve the accessibility of these products. See 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices . 3.6 Ongoing Obligations Imposed by Marketing Authorisations A drug MAH (and its local MAH deputy, if it is an over- seas MAH) has the following post-marketing obliga- tions under the DAL and relevant regulations: • establishing and implementing a pharmacovigi- lance system; • conducting regular post-market launch appraisals; • establishing a release process for drug market launches; • establishing and implementing a drug-tracking system; and • establishing an annual report system. The NMPA has promulgated Guidelines on Pharma- covigilance Inspections and Good Practice for Phar- macovigilance Systems to guide a drug MAH in estab- lishing a pharmacovigilance system.
Furthermore, the DAL Rules and Provisions on the Supervision and Administration of Drug Marketing Authorisation Holder Implementation of the Main Responsibility of Drug Quality and Safety summarise and re-emphasise the quality and safety management throughout the entire drug life cycle, and clarify the key responsibilities of a MAH that were previously scattered across the DAL and other laws and regula- tions. A medical device MAH is also responsible for post- marketing obligations, including: • establishing and maintaining a quality management system; • setting up and implementing the post-marketing research and risk management and control plan; • monitoring and re-evaluating medical device adverse events; and • establishing a tracking and recall system. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations The official websites for the CDE (for drugs), the CMDE (for medical devices) and the NMPA (for both drugs and medical devices) enable third-party access to certain information regarding pending, rejected and approved marketing authorisations. Pharmaceuticals For drugs pending approval, information such as acceptance number, drug name, drug type, appli- cation type, registration category, company name, accepted date and registration application status is publicly available on the CDE’s official website. The public can also access granted marketing authorisa- tion information such as approval number, manufac- turing enterprise with production site, approved date, dosage form and specification via the relevant data- base on the NMPA’s official website. Third parties can access refused application information on the NMPA’s
official website. Medical Devices
Third parties can access less information about medi- cal devices compared to drugs. The pending market- ing authorisation information is only available to appli- cants. Refused marketing authorisation information
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