CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
the change, except for changes related to drug security. The NMPA issued the Administrative Measures for Drug Standards in 2023, requiring the MAHs to submit the proposed standards for drug regis- tration during their applications or supplemental applications. Any change to registration stand- ards requires a supplementary application, filing or report, depending on the risk levels. In 2024, the General Office of the State Coun- cil promulgated certain opinions, requiring rel- evant authorities to improve the quality and efficiency of the review and approval of drugs and medical devices, such as shorter review and approval time, less inspection quantity and batches. Detailed measures are to be issued by the NMPA. Medical Devices Class II and III medical devices are administrated by the registration process, while Class I medical devices are administrated by the filing process. The following processes are generally required to obtain a new marketing authorisation: • submission of a technical product testing report; • submission of the clinical evaluation for the clinical data to confirm safety and effective- ness, if required by law; • examination of the quality management sys- tem, which will comply with good manufac- turing practices; • submission of the registration application documents; and • regulatory review by the CMDE and the NMPA/provincial MPA.
Changes to these marketing authorisations are divided into modification registration item vari- ations (eg, change of product specification or technical requirements) and filing item variations (eg, change of the MAH’s name or address). Both currently need to be approved by the NMPA/provincial MPA. Changes to modification registration items may trigger an additional tech- nical review by the CMDE. There is no definitive regulation to permit the transfer of the market- ing authorisation of medical devices. Having said that, the MDAL Draft expressly allows the medical device registrant, namely the MAH, to transfer the registration certificate upon approval by the competent MPA, provided that the trans- feree is capable of quality management and risk prevention and control. It remains uncertain whether the transfer will also be allowed in the final version. Regarding the application for Class I devices, the provincial MPA (for domestic devices) or the NMPA (for imported devices) will be provided with the filing materials, which are generally the same as those for Class II and III medical devic- es administrated by the registration process. The MAH must file any changes to the filing items of Class I devices with the original filing authority. Subject to these procedures, the NMPA has required registration applications for drugs and certain medical devices to be conducted via the electronic system since 2022. In order to facili- tate applicants, the CDE continues to optimise and update the software for the production of electronic application materials. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations The DAL explicitly establishes an expanded access programme allowing physicians and
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