Report from our correspondent (Reporter Zhang Xiaomei) the official website of the State Food and Drug Administration released the relevant policies (draft for comments) on encouraging the innovation of drugs and medical devices and accelerating the review and approval of the listing of new drugs and medical devices. The listing of three types of injections will be strictly controlled. Among them, if oral preparations can meet clinical needs, injection preparations are not approved for listing.
Strict injection review and approval
According to the draft for comments, the review and approval of injections are further tightened. Under the three types of cases, injections are no longer approved for listing.
Three kinds of situations are respectively, strictly control the oral preparation to injection, where the oral preparation can meet the clinical needs, do not approve the injection preparation listed; Strictly control the intramuscular injection preparation to intravenous injection preparation, where the intramuscular injection preparation can meet the clinical needs, the intravenous injection preparation is not approved for listing; The application for mutual modification of dosage forms among large-volume injection, small-volume injection and sterile powder injection for injection, those without obvious clinical advantages will not be approved.
Urgent drugs and rare diseases can be quickly approved
The General Administration of Food and Drug Administration will speed up the review and approval of urgently needed drugs and medical devices in clinical practice. Included in the accelerated review and approval include: drugs and medical devices that treat diseases that are seriously life-threatening and have no effective treatment methods, drugs and medical devices that are of great significance in solving clinical needs, early clinical trials, if the medium-term index shows the curative effect and can predict its clinical value, it can be approved for listing conditionally. At the same time, innovative drugs and medical devices listed in major national science and technology projects and supported by national key research and development plans will be given priority review and approval.
In the aspect of rare disease treatment, it supports the research and development of rare disease treatment drugs and medical devices. The Health and Family Planning Department will publish the list of rare diseases and establish a registration system for patients with rare diseases. Applicants for rare disease treatment drugs and medical devices can apply for exemption from clinical trials to accelerate the review and approval of rare disease medication medical devices. For rare disease treatment drugs and medical devices that have been approved to be listed abroad, they can be approved to be listed on condition, and relevant research can be made up within the specified time after being listed.
Support innovative drugs to be included in basic health insurance
Encourage medical institutions to give priority to purchasing and using new drugs with clear curative effect and reasonable price. Research and improve the dynamic adjustment mechanism of medical insurance drug list, explore the establishment of medical insurance drug payment standard negotiation system, and support innovative drugs to be included in the basic medical insurance payment scope according to regulations.
Support Chinese medicine preservation and innovation. Innovative traditional Chinese medicine shall be reviewed and approved according to the standard of “new curative effect”; New improved traditional Chinese medicine shall reflect the advantages of clinical application; Traditional Chinese medicine shall be reviewed and approved according to the simplified standard; Natural drugs, review and approve according to modern medical standards. The State Food and Drug Administration will also guide the research and development of new Chinese medicine drugs oriented by clinical value to promote the sustainable utilization of Chinese medicine resources.
(Reporter Zhang Xiaomei) the official website of the State Food and Drug Administration released the relevant policies (draft for comments) on encouraging the innovation of drugs and medical devices and accelerating the review and approval of the listing of new drugs and medical devices. The listing of three types of injections will be strictly controlled. Among them, mouth