State Food and Drug Administration: accelerate the approval of overseas new drug listing to benefit Chinese patients as soon as possible

On Tuesday, the Information Office of the State Council held a regular briefing on the policies of the State Council Jiao Hong, director of the State Drug Administration, introduced the work related to accelerating the review and approval of new drugs for overseas listing Jiao Hong said that medicine is a special commodity for curing diseases and saving people, which is related to the vital interests of the people and the most basic livelihood issue The CPC Central Committee and the State Council attach great importance to the reform of the review and approval system of medical devices, and accelerating the review and approval of new drugs listed abroad is an important part The SFDA earnestly implemented the requirements of the meeting of the State Council, promptly issued the policy of simplifying the approval of new drugs for overseas listing, rapidly approved a batch of new drugs for overseas listing, and made positive progress in accelerating the review and approval of new drugs for overseas listing Since the executive meeting of the State Council on April 12, the SFDA has carried out the following work First, simplify the examination and approval procedures for new drugs listed overseas In May this year, the drug regulatory bureau, together with the Health Commission, issued the announcement on optimizing matters related to the review and approval of drug registration, greatly simplifying the approval procedures for new drugs listed overseas For the drugs that have been listed abroad to prevent and treat diseases and rare diseases that are seriously life-threatening and have no effective treatment means, and there is no ethnic difference confirmed by research, the applicant does not need to apply for clinical trials, and can directly apply for listing with overseas trial data, and the time of drug listing will be accelerated by 1-2 years; for the overseas new drugs that need to carry out clinical trials in China, clinical trials will be conducted The registration inspection at the stage is adjusted from inspection one by one to inspection according to the needs of evaluation, so as to shorten the preparation time of enterprise inspection samples and accelerate the listing of new drugs abroad The second is to optimize the approval procedures of drug clinical trials The notice on adjusting the review and approval of clinical trials of drugs (Trial) has been drafted by the drug administration, and opinions are being solicited publicly After the formal implementation of the announcement, the clinical trial application changed from the approval system to the expiration default system Within 60 days from the date of acceptance of the clinical trial application, if no negative or query opinions are received, the applicant can carry out the clinical trial in accordance with the submitted scheme to save time and cost for the enterprise The third is to cancel the batch by batch compulsory inspection of imported chemicals In April this year, the SFDA issued the announcement on relevant matters concerning the customs clearance and inspection of imported chemicals, which cancelled the port inspection of imported chemicals and strengthened the supervision and sampling inspection after listing After the implementation of the policy, imported chemicals can be directly distributed to medical institutions and retail pharmacies after customs clearance at ports, which can shorten the time to enter the Chinese market by 2-3 months and reduce the cost of foreign new drugs entering the Chinese market Jiao Hong said that by taking the above measures, the SFDA has recently accelerated the approval of seven overseas new drugs for the prevention and control of serious life-threatening diseases, and the effectiveness of accelerating the review and approval of overseas listed drugs has initially appeared Next, the SFDA will further implement the deployment of the State Council, accelerate the review and approval of drugs urgently needed in clinical practice, implement policies and measures to encourage the listing of new drugs; strengthen the construction of professional inspectors, strengthen the supervision during and after the event, and strengthen the overseas inspection, so that the international pharmaceutical innovation results can benefit the patients in China as soon as possible.