CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
months from the date of approval to implement the change, except for changes related to drug security. The NMPA issued the Administrative Measures for Drug Standards in 2023, requiring MAHs to submit the proposed standards for drug registration during their applications or supplemental applications. Any change to registration standards requires a supple- mentary application, filing or report, depending on the risk levels. Since 2024, the General Office of the State Council and the NMPA have promulgated certain opinions and notifications to improve the quality and efficiency of the review and approval of drugs through well-defined mechanisms, such as guidance before submission, shorter review and approval time, less inspection quantity and batches. In 2024 and 2025, the NMPA approved multiple provincial MPAs to launch pilot reforms of the review and approval procedures for supplementary drug applications, and detailed reform measures have been released by these MPAs. 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 effectiveness, if required by law; • examination of the quality management system, which must comply with good manufacturing prac- tices; • submission of the registration application docu- ments; and • regulatory review by the CMDE and the NMPA/pro- vincial MPA. Changes to these marketing authorisations are divid- ed into modification registration item variations (eg, change of product specification or technical require- ments) 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 addi- tional technical review by the CMDE. There is no definitive regulation to permit the transfer of the mar- keting authorisation of medical devices. That said, the MDAL Draft expressly allows the medical device registrant – namely the MAH – to transfer the registra- tion certificate upon approval by the competent MPA, provided that the transferee is capable of quality man- agement 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 devices 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 medical devic- es to be conducted via the electronic system. In order to facilitate applicants, the CDE and CMDE continue to optimise and update the software and system for the electronic application. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations The DAL explicitly establishes an expanded access programme that allows physicians and 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 setting but with similar conditions.
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