CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao, Stephanie Wang and Rae Zhang, Global Law Office
• if the major utility of a combination product cannot be easily identified, the applicant will apply for the product attribute identification with the NMPA and submit a registration application accordingly. 3.2 Marketing Authorisation for Biologic Medicinal Products Marketing authorisation applications for biologic medicinal products generally follow a similar process as outlined in 3.1 Product Classification: Pharma - ceuticals or Medical Devices . That said, the CDE has promulgated and kept updating the specific guidelines for review of the marketing authorisation applications of biologic medicinal products, and it is compulsory to conduct verification and examination on manufactur- ing sites and pre-market Good Manufacturing Prac- tice (GMP) inspections for biologic medicinal products being registered, while the verification and examina- tion of other drugs is subject to the CDE’s discretion. 3.3 Period of Validity of Marketing Authorisations Marketing authorisations for drugs and Class II and III medical devices are valid for five years and can be renewed for another five years. Marketing authorisa- tions for Class I medical devices (ie, filing receipts) do not expire. The NMPA can revoke a marketing authorisation for reasons such as: • the conducting of clinical trials without pre-approv- al; • the use of unapproved package materials or con- tainers; and • the use of unapproved labels or instructions, bribery, obtainment of a marketing authorisation by fraudulent means, etc. Conversely, the NMPA could cancel the marketing authorisation if an approved product lacks effective- ness, has material adverse effects or poses risks to human health. 3.4 Procedure for Obtaining a Marketing Authorisation There are three types of registration applications for drugs:
• drug registration applications; • re-registration applications; and • supplemental applications. Drug Registration The following steps are generally required in a drug registration: • study prior to clinical trials; • clinical trials; • submission of a drug registration application; • registration verification and examination; and • registration inspection. For overseas-manufactured drugs already marketed abroad that are to be produced in China, the domes- tic applicant must file an application for marketing authorisation for such drugs in accordance with pro- cedures and requirements corresponding to the type of the drugs. Applications for chemical drugs must fol- lowing the procedures for generic drugs, therapeutic biologic products must follow Class 3.4 (other) thera- peutic biological products, and prophylactic biological products must follow Class 3.3 prophylactic biological products (vaccines already marketed in China). Re-Registration This is applicable when renewing a valid drug market- ing authorisation before expiry. The NMPA has prom- ulgated detailed application procedures and require- ments on application documents for re-registration of drugs. Certain provincial MPAs have further optimised and refined relevant procedures and requirements These are generally required for changes to drugs with marketing authorisation, such as material changes in the drug manufacturing, changes related to drug effect and risks in the instructions, changes of the MAH, registration standards, etc. Notably, when changing the MAH, the transferee must be capable of quality management, risk prevention and control, and of pro- viding liability compensation to ensure drug safety, effect and quality control, among other requirements generally applicable to MAHs. For approved changes, the MAH may be granted a grace period of up to six according to actual situations. Supplemental Applications
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