The State Food and Drug Administration will improve the management of drug registration

Today is the deadline for the State Food and Drug Administration (the "State Administration of Food and Drug Administration") to request feedback from 16 agencies under its "Notice on Strengthening drug registration management to further clarify the acceptance of work requirements" (hereinafter referred to as the "Notice"). Although the Notice is still in the consultation stage, there are still some positive signs that the State Administration of Food and Drug Administration is expected to improve the management of drug registration.
Regarding the registration of new drugs, the Notice stipulates that: to apply for the registration of domestic and imported drugs, the application for clinical registration shall be submitted first according to the procedure, and the application for listing and registration shall be submitted after approval; Application for listing registration; after approval of clinical application for registration in category 3 of chemical drugs, if the same variety of imported drugs is approved for listing, the applicant may, at his option, conduct a clinical trial of biological equivalents in accordance with category 3 of chemicals or a class 6 of chemicals to carry out a bioethicity test and be included in a generic drug sequence; and apply for clinical registration of a preparation in categories 1 to 4 of a chemical, and at the same time apply for clinical registration of the API used, and apply for clinical registration of only new pharmaceutical raw materials.
on the registration application of generic drugs: according to the registration application of chemical drugs category 6 declaration, the first declaration in accordance with the listing registration procedure declaration, after review can be reduced clinical, can be directly approved for listing. Declared drugs with the same active ingredients and dosage forms of listed drugs but different specifications, in accordance with the generic procedures.
Regarding the associated declaration of RAW drugs and preparations: When the application for registration of preparations is accepted, the source of the API shall be examined, and if the API is not approved for listing (import), a copy of the acceptance notice of the application for registration of API shall be provided, and the acceptance number of the associated API, the combined review of the API and preparation; Application for clinical registration procedures for pharmaceutical products; for raw materials and preparations declared in accordance with categories 3 and 6 for chemicals respectively, for applications for 3 types of API in accordance with the clinical registration procedures for new drugs, for which the review preparation can be approved directly for listing, the review department shall notify the applicant of other relevant materials required by the application process for the listing of raw materials, and if the preparation requires clinical trials, the raw materials and preparations shall be approved for clinical trials at the same time, and after completing clinical trials, the raw materials shall be declared in accordance with the listing application procedure.
The State Administration of Food and Drug Administration has just published a list of over-repeated drug varieties, from the "Notice", the State Administration of Food and Drug Administration will limit the declaration of over-repetitive drugs, which on the other hand protects the approved and into the monitoring period of new drugs.
, the Notice shows that the State Administration of Food and Drug Administration will reduce the technical aspects of new drugs, especially generic drugs approval time. However, from the "Notice", the State Administration of Food and Drug Administration did not mention the drug registration and declaration procedures, time limits, approval authority and other aspects of the reform. (Phoenix.com)