CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
registration review (130 days) for innovative drugs that fall within their scope. Likewise, there are certain special procedures to shorten the time or facilitate the registration review of medical devices, under relevant regula- tions, including the following. • A registration procedure for an innovative medical device. • A priority registration procedure for medical devices that: (a) have obvious clinical advantages for certain diseases or are in urgent clinical demand without homogeneous approved medical devices; and (b) are listed in the national key R&D pro- jects. • An emergency registration procedure for medical devices required in public health emergencies. 4.2 Regulatory Reliance In terms of medical products that have obtained authorisations in other jurisdictions, China has introduced special rules for the registration of these medical products to strengthen interna- tional exchanges and co-operation. For drugs that have been authorised to market from internationally recognised jurisdictions, supporting documents (with notarised instru- ments and Chinese translations) proving the overseas permits for marketing should be sub- mitted for the application for market authorisa- tion in the PRC. Drugs that have already been marketed overseas are classified into different categories (ie, Class 5 for chemical drugs, and Class 3.1 and 3.2 for prophylactic/therapeutic biologics), and applications are submitted based on different registration classifications and dec- laration documents.
Overseas research information and data could be used to support drug registration in the PRC if the sources, research institutions or laboratory conditions, quality system requirements, and other management conditions are in line with the prevailing principles of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (the “ICHR” ), and comply with the relevant requirements for the administration of drug reg- istration in the PRC. Compared with the general review time limit of 200 days, the review time limit for rare disease drugs with urgent clinical needs that have been marketed overseas but are yet to be marketed in the PRC would be short- ened to no more than 70 days. An application for imported medical devices is required to be submitted to the NMPA for the filing (Class I)/application for review (Class II and Class III). Supporting documents are also of the essence when submitting the application to prove that competent authorities permit the marketing of these medical devices. In terms of the timeframe for acceptance, technical review, verification and approval of registration, there is no specific process for accelerated approval for the filing/registration of imported medical devices. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices Pharmaceuticals Pharmaceutical manufacturing plants are required to obtain drug manufacturing licences, even for MAHs that lack manufacturing capac-
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