CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products Marketing authorisation applications for biolog- ic medicinal products generally follow a similar process outlined in 3.1 Product Classification: Pharmaceuticals or Medical Devices . Having said that, it is compulsory to conduct verifica- tion and examination on manufacturing sites and pre-market GMP inspections for biologic medicinal products being registered, while the verification and examination of other drugs is subject to the CDE’s discretion. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices Marketing authorisations for drugs and Class II and III medical devices are valid for five years and can be renewed for another five years. Mar- keting authorisations 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- approval; • the use of unapproved package materials or containers; and • the use of unapproved labels or instructions, bribery, obtainment of a marketing authorisa- tion by fraudulent means, etc. Conversely, the NMPA could cancel the market- ing authorisation if an approved product lacks effectiveness, has material adverse effects or poses risks to human health.
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices 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. Re-Registration This is applicable when renewing a valid drug marketing authorisation before expiry. The NMPA has promulgated detailed application procedures and documents for re-registration of drugs. Supplemental Applications 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 instruc- tions, changes of the marketing authorisation holder (the “MAH” ), registration standards, etc. Notably, when changing the MAH, the transferee must be capable of quality management, risk prevention and control, and of providing liabil- ity compensation to ensure drug safety, effect and quality control. For approved changes, the MAH may be granted a grace period of up to six months from the date of approval to implement
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