Notice issued by the drug regulatory bureau: accelerating the review and approval of overseas new drugs urgently needed in clinical practice

[policies and regulations of chinapharma.com] in order to speed up the review and approval of clinically urgently needed new drugs for overseas listing, on October 30, the state issued the announcement on matters related to the review and approval of clinically urgently needed new drugs for overseas listing (No 79, 2018) (hereinafter referred to as the "announcement") (notice issued by SFDA: accelerating the review and approval of overseas new drugs urgently needed in clinical practice source: chinapharma.com) According to the announcement, if the new drugs listed in the United States, the European Union or Japan but not listed in China in the past decade meet one of the three conditions, the drug review center will establish a special channel for review and approval, and complete the technical review within three months after the acceptance of the new rare disease treatment products; for other overseas new drugs, complete the technical review within six months after the acceptance The three situations are: drugs used to treat rare diseases; drugs used to prevent and control serious life-threatening diseases without effective treatment or prevention means; drugs used to prevent and control serious life-threatening diseases with obvious clinical advantages The author has learned that the procedure of variety selection includes the process of drug selection, preliminary screening, expert demonstration, publicity and publication The SDA shall make a decision on examination and approval within 10 working days after receiving the examination materials submitted by the drug examination center With regard to the selection of varieties, the State Drug Administration and the national health and Health Commission will organize and carry out the selection of varieties in accordance with the scope of varieties mentioned above, guided by the clinical value and following the principles of openness, fairness and justice It is reported that the specific process of variety selection will be divided into four steps Step, carry out preliminary screening The drug evaluation center of the state drug administration organizes experts to sort out the new drugs listed in the United States, the European Union and Japan but not listed in China in the past decade, and preliminarily select the varieties that meet the requirements of this procedure The second step is expert demonstration The State Drug Administration and the national health and Health Commission hold an expert demonstration meeting to demonstrate the list of initially selected varieties and select the list of varieties that meet the requirements of this procedure according to the expert opinions The third step is publicity The drug Audit Center shall publicize the list of selected varieties to the public, and submit written opinions and reasons to the drug audit center within 5 days in case of any objection to the publicized varieties For the dissenting varieties, a decision shall be made after another demonstration and the parties concerned shall be informed Step four, release The drug evaluation center of the State Drug Administration issues a list of varieties to be included in the review and approval of special channels In addition, the announcement also puts forward relevant work requirements: overseas new drug applicants should develop risk management and control technology, timely report the adverse reactions, assess the risk situation, propose improvement measures, and conduct continuous research on the listed drugs, and complete relevant research work according to the approval requirements Second, for the products manufactured before the approval documents of imported drugs are obtained, the applicant is allowed to import and conduct inspection according to law on the premise that the production process and registration standards of the products are consistent with those approved by the State Drug Administration Third, the SDA may carry out the verification of clinical trial data according to the needs of technical review after the approval of listing At the same time, strengthen the monitoring and re evaluation of adverse reactions after marketing, and take emergency control measures to stop the sale and use of drugs that have been confirmed to have serious adverse reactions The speed-up of new drug review and approval is not only good news for patients, but also good news for Chinese pharmaceutical enterprises It helps pharmaceutical enterprises to increase R & D investment, release innovation potential and enhance innovation ability, so as to promote the development of pharmaceutical industry and benefit the people.