The General Office of the China Food and Drug Administration ("CFDA") has recently issued the Administrative Measures for the Disclosure of Information on the Drug Evaluation and Approval (Draft for Comment) (the "Draft for Comment") for public consultation by February 21, 2018.
The Draft for Comment prescribes that information about the evaluation and approval of drugs shall be made public in a fair, timely, accurate, and easily accessible manner, and any State secrets, applicant's trade secrets and know-how, and individual privacy shall be kept confidential. Major information to be published includes details on the acceptance of the drug registration application, information about the evaluation and approval process, evaluation and approval results, and other information relating to the evaluation and approval. According to the Draft for Comment, the Center for Drug Evaluation under the CFDA shall, within ten working days upon the acceptance of a drug registration application, make public the application acceptance number for the drug variety at issue to be registered, the drug name and the date when the application is accepted, etc. according to the classification into traditional Chinese medicine, chemical medicine and biological products, In addition, the Draft for Comment expressly states that for innovator drugs, improved new drugs and generic drugs, that have been approved for the marketing, the Center for Drug Evaluation shall, within 60 working days after these drugs have been launched on the market upon approval, release information on technical evaluation to the public.