CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
• monitoring and re-evaluating medical device adverse events; and • establishing a tracking and recall system. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices The official websites for the CDE (for drugs), the CMDE (for medical devices) and the NMPA (for both drugs and medical devices) enable third- party access to certain information regarding pending, rejected and approved marketing authorisations. Pharmaceuticals For drugs pending approval, information such as acceptance number, drug name, drug type, application type, registration category, company name, accepted date and registration applica- tion status is publicly available on the CDE’s offi- cial website. The public can also access granted marketing authorisation information such as approval number, manufacturing enterprise with production site, approved date, dosage form and specification via the relevant database on the NMPA’s official website. Third parties can access refused application information on the NMPA’s official website. Medical Devices Third parties can access less information about medical devices compared to drugs. The pend- ing marketing authorisation information is only available to applicants. Refused marketing authorisation information for refused devices, including acceptance number, device name, the applicant and its local deputy (if it is an over- seas medical device), can be accessed on the NMPA’s official website. Marketing authorisa- tion information for permitted devices is pub- licly available on the NMPA’s official website, including the marketing authorisation number,
the MAH’s name and address, the manufactur- ing site, the device’s name, type, specifications, structure, components, applicable scope and intended use, the approval date, the effective date and modified information. The government is prohibited from disclosing any commercial secrets (such as manufac- turing processes, key technical parameters, know-how, tests and data) or personal priva- cy 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 proce- dures to shorten the time or facilitate the regis- tration 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 clinical values; and • registration for drugs that are required to con- front public health emergencies. Specifically, the CDE has issued specifications on facilitating the registration review of mar- keting authorisation applications for innova- tive drugs that are specific to children, used for the treatment of rare diseases or applicable to special procedures for drugs with breakthrough effects. These specifications clearly outline the timeframe for communications (30 days) and
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