CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
3. Marketing Authorisations 3.1 Product Classification
personal information protection, online advertising, etc. 2.5 Use of Data From Clinical Trials Raw data generated from clinical trials may include tri- al subjects’ personal information, health data, genetic resources, etc. The Personal Information Protection Law (PIPL) pro- vides a legal framework for the administration of han- dling personal information. During clinical trials, sites, principal investigators, sponsor-designated monitors and other third parties may access trial subjects’ per- sonal information. However, sponsors will generally only receive coded data from the trial. Moreover, the sharing and transferring of personal data is subject to other statutory requirements, such as the receipt of data subjects’ consent, restrictions on cross-border data transfer, etc. In March 2024, the Cyberspace Administration of China issued the Provisions on Pro - moting and Regulating Cross-border Data Flow, which refines the specific requirements for cross-border data transfer. Human genetic resource (HGR) samples and data are governed by the Biosecurity Law and the Adminis- trative Regulation on Human Genetic Resources (the “HGR Regulation”). Foreign parties are currently only permitted to use Chinese HGR upon filing/approval by the HGR authority and under co-operation with Chinese parties. Failure to obtain the filing/approval may result in administrative liabilities or even crimi- nal liabilities. The Implementation Rules on the HGR Regulation provide specific guidance on determining foreign parties and a more specific scope of HGR, excluding clinical data, imaging data, protein data and metabolic data from the scope of the HGR Regulation. 2.6 Personal or Sensitive Data In addition to the statutory requirements set out in 2.5 Use of Data From Clinical Trials , the Guidelines for Clinical Trial Data Management issued by the NMPA set out the basic standards for the responsibility, qualification and training of parties responsible for data management, and requirements for the design of data management systems, the standardisation of clinical trial data, quality control and the assessment of clinical data.
The DAL defines a “drug” as a substance used to pre- vent, treat or diagnose human diseases and intended to regulate human physiological functions, for which usage and dosage are specified for indication/primary treatment. The list of types of drugs includes tradi- tional Chinese medicines, chemical drugs and bio- logical products. The CDE evaluates drug marketing authorisation applications submitted by manufactur- ers or development institutions. The term “medical devices” refers to instruments, equipment, appliances, IVD reagents and calibrators, materials and other similar or related articles (includ- ing computer software) that can be used directly or indirectly with human bodies to achieve specified purposes (such as diagnosis, prevention and moni- toring) and whose effectiveness is primarily achieved by physical or other similar means rather than by phar- macological, immunological or metabolic means (or under circumstances where these latter means only serve auxiliary functions). The Center for Medical Device Evaluation (CMDE) of the NMPA is responsible for the technical evalua- tion of medical devices. The NMPA has released the Announcement on Standardising the Identification of the Classification of Medical Device Products, out- lining general processes for classification of medi- cal devices and specific procedures to apply for the classification of newly developed medical devices that have never been classified before or medical devices with classification uncertainty due to new or increased risks. The NMPA has issued and constantly updated the Medical Device Classification Catalogue, indicat- ing its commitment to maintaining the regulatory envi- ronment with the rapid development of medical device technologies and the industry. The following applies to products containing both a drug and a device (ie, a combination product): • applicants should apply for its registration as a drug if the product mainly acts as a drug, and as a medical device if the product mainly acts as a medical device; and
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