Today, the State Food and Drug Administration (hereinafter referred to as the “National Food and Drug Administration”) requested 16 agencies to give feedback to the “Notice on Strengthening the Registration of Drugs to Further Clarify the Acceptance of Work Requirements” (hereinafter referred to as the “Notice”). Deadline. Although the Notice is still in the stage of soliciting opinions, it still shows some positive signals. The State Food and Drug Administration is expected to improve the registration of drugs.
Regarding the registration of new drugs, the "Notice" stipulates that: for the registration of domestic and imported drugs, the application for clinical registration should be submitted first according to the procedure, and the application for listing registration should be submitted after approval; but the ordinary or specific immunoglobulin and human albumin injected intramuscularly Products, compound electrolyte injection, blood volume expander products can be submitted directly to the application for listing registration; new drugs will not accept the registration application for the same active ingredient variety from the date of monitoring; if it has been approved for clinical, it can accept the application for listing registration; After the registration application for the registration of chemical drugs is approved for clinical use, if the imported drugs of the same variety are approved for listing, the applicant may choose to conduct clinical tests or biochemical equivalence tests in six categories of chemical drugs to carry out bioequivalence. For the test, the generic drug sequence shall be included; according to the clinical registration application for the preparation of the chemical category 1-4, the clinical registration application of the raw material drug to be used shall be submitted at the same time, and only the application for clinical registration of the new drug raw material drug shall be submitted, and no approval will be granted.
About the application for registration of generic drugs: According to the registration application for the 6 types of chemical drugs, the first application is declared in accordance with the listing registration procedure. If the clinical evaluation can be reduced or exempted, the listing can be directly approved. If the declared drug is the same as the active ingredient and dosage form of the listed drug, but the specifications are different, it shall be accepted in accordance with the generic drug program.
Regarding the registration of APIs and preparations: When the application for registration of the preparation is accepted, the source of the API should be reviewed. If the API is not approved for listing (import), a copy of the notification of acceptance of the registration of the API should be provided, and the relevant APIs should be The acceptance number, the bulk drug and the preparation are combined for review; the raw material drug and the preparation are declared according to the chemical category 3 and 5 respectively, and the first declaration of the raw material drug and preparation should be applied according to the clinical registration procedure of the new drug; the raw material drug and the preparation are respectively according to the chemical For Class 3 and Class 6 declared, Class 3 APIs shall be applied in accordance with the clinical registration procedures for new drugs. If the approved preparations can be directly approved for listing, the reviewing department shall notify the applicant to supplement other relevant materials required by the application procedures for the listing of APIs. If the preparation needs to be tested in clinical trials, the raw materials and preparations shall be approved at the same time. After the clinical trial is completed, the raw materials shall be declared in accordance with the application procedures for listing registration.
The State Food and Drug Administration has just published a list of over-repeated drug varieties. From the Notice, the State Food and Drug Administration will limit the declaration of excessively repeated drugs, which on the other hand protects the approved and entered monitoring period. New drug.
At the same time, the "Notice" shows that the State Food and Drug Administration will shorten the approval time for new drugs, especially generic drugs. However, from the "Notice", the State Food and Drug Administration has not mentioned the reform of the procedures for the registration of drugs, time limits, and decentralization of examination and approval.