CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
for refused devices, including acceptance number, device name, the applicant and its local deputy (if it is an overseas medical device), can be accessed on the NMPA’s official website. Marketing authorisation information for permitted devices is publicly available on the NMPA’s official website, including the mar- keting authorisation number, the MAH’s name and address, the manufacturing site, the device’s name, type, specifications, structure, components, applica- ble scope and intended use, the approval date, the effective date and modified information. The government is prohibited from disclosing any commercial secrets (such as manufacturing process- es, key technical parameters, know-how, tests and data) or personal privacy accessed during review and examination, unless the rights-holder has granted its consent or unless non-disclosure will have a material adverse effect on public interests. 4. Regulatory Reliance and Fast-Track Registration Routes 4.1 Fast-Track Registration Routes The NMPA provides four kinds of special procedures to shorten the time or facilitate the registration review of drugs, as follows: • registration for drugs with breakthrough effects; • registration for drugs with additional approval conditions; • fast-track registration for drugs with obvious clini- cal values; and • registration for drugs that are required to confront public health emergencies. Specifically, the CDE has issued specifications on facilitating the registration review of marketing author- isation applications for innovative drugs that are spe- cific to children, used for the treatment of rare dis- eases or applicable to special procedures for drugs with breakthrough effects. These specifications clearly outline the timeframe for communications (30 days) and 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 regulations, 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 with- out homogeneous approved medical devices; (b) are listed in the national key R&D projects; and (c) are eligible for the priority registration proce- dure in accordance with the explicit provisions of the NMPA – eg, the Catalogue of High-end Medical Devices for Priority Approval (2025 Edition) issued by the NMPA. • 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 intro- duced special rules (eg, products in fast-track regis- tration, reducing the quantity for registration testing, etc) for the registration of these medical products to enhance product accessibility and strengthen interna- tional exchanges and co-operation. For drugs that have been authorised to market from internationally recognised jurisdictions, supporting documents (with notarised instruments and Chinese translations) proving the overseas permits for market- ing should be submitted for the application for mar- ket authorisation 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 reg- istration classifications and declaration documents. Compared with the general review time limit of 200 working days, the review time limit for the market authorisation applications of rare disease drugs with urgent clinical needs that have been marketed over- seas but are yet to be marketed in the PRC would be shortened to no more than 70 working days.
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