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New rules of drug registration process issued by CFDA

Writer:CFDA|Source:CFDA|NewsTime:2020-09-10 10:20:31

Recently, in order to further standardize the acceptance of drug registration, the State Food and Drug Administration issued the notice on further standardizing the acceptance of drug registration.
The time of examination and approval is strictly stipulated in the notice. "All provincial bureaus shall, in strict accordance with the" measures for the administration of drug registration "and relevant provisions, complete the formal review of the application materials within 5 working days, and inform the applicant of all the contents to be supplemented and corrected at one time. If the contents still fail to meet the requirements after the rectification, they will not be accepted.". "Complete the examination of application materials, on-site registration verification, production site inspection, sampling and notification of drug inspection institutions for registration inspection within 30 working days after accepting the application.".
This reminds us of the incident that Vietnamese pharmaceutical enterprises won the CFDA at the beginning of this year. The cause of this incident was that the approval time was seriously overtime, which lasted for more than 500 days; finally, the API was rejected because there was no approval, but the manufacturer was not informed of the supplementary materials in time.
It is believed that after the implementation of the notice, the occurrence of similar drug approval tragedies can be greatly reduced.
It is mentioned in the notice that "generic drugs shall be applied according to the registration application for six categories of chemical drugs, and the first application shall be made in accordance with the production registration procedures for declaration. If the clinical application can be reduced or reduced after evaluation, it can be directly approved for listing; if it can not be exempted from clinical application, clinical trials shall be approved.". That is to say, there are already generic drugs in China, and if they are imitated, the time will be shortened. The shortening time mainly comes from the bioequivalence review which takes 8 to 10 months.
 

  
To the food and Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government:
In order to further standardize the acceptance of drug registration, the supplementary requirements for the examination of drug registration form (see Annex) are hereby printed and distributed. Please abide by the supplementary requirements and notify the relevant requirements as follows:
1、 All provincial bureaus shall, in strict accordance with the "measures for the administration of drug registration" and relevant provisions, complete the formal review of the application materials within 5 working days, and inform the applicant of all the contents to be supplemented and corrected at one time. If the contents still fail to meet the requirements after correction, they will not be accepted.
2、 All provincial bureaus shall, in strict accordance with the measures for the administration of drug registration and relevant regulations, complete the review of application materials, on-site registration verification, on-site inspection of production, sampling and notification of drug inspection institutions for registration inspection within 30 working days after accepting the application. After confirming that the above-mentioned verification and inspection results meet the relevant provisions, the review opinions shall be submitted together with the verification report and application materials to the State Administration of taxation. If the results of verification, inspection and sample inspection do not meet the requirements, the application materials shall be returned.
3、 All review, verification, on-site inspection and inspection shall indicate the specific handling personnel, and shall bear legal responsibility for the authenticity of their review, verification and other work. If any dereliction of duty, dereliction of duty or fraud is found, the General Administration will file a case for accountability.
4、 All localities should promptly correct problems such as incomplete acceptance data, inaccurate registration classification, number grabbing and over time acceptance.
5、 All personnel participating in the above-mentioned review, verification, on-site inspection and inspection shall participate in the training and pass the examination before taking up their posts. The incompetent should be adjusted in time. New problems encountered in the acceptance work shall be reported to the General Administration in a timely manner.
6、 The General Administration of the people's Republic of China will inspect the acceptance of the provincial bureaus, issue a notice of criticism to those who have clearly stipulated that they can not accept but still accept the work beyond the working time limit without reasonable explanation, and investigate the responsibilities of the relevant personnel and the leadership responsibilities of the responsible comrades in charge of the Provincial Bureau. If the problem is serious, its acceptance qualification shall be suspended.
7、 In order to further guide the application and acceptance of drug registration, the General Administration of the people's Republic of China will continue to issue announcements of excessive duplicate varieties, and provincial bureaus should guide enterprises to apply rationally.

General Administration of food and Drug Administration
enclosure:
Supplementary requirements for drug registration form review
1、 Application for new drug registration
(1) For new drugs, domestic drugs and imported drugs applied according to the new drug procedure, clinical trial application shall be submitted first according to the procedure, and then the application for production / import registration shall be submitted again after approval.
Intramuscular injection of ordinary or specific human immunoglobulin, human serum albumin, compound electrolyte injection, blood volume expansion agent and other products can be directly submitted to the application for production / import registration.
(2) To apply for the registration application for additional indications in categories 1.6 and 3.4 of Annex 2 to the measures for the administration of drug registration, the varieties shall be the same as the active ingredients, dosage forms and administration routes of the marketed drugs.
The application for registration of new indications added to category 1.6 and 3.4 of chemical drugs shall be submitted by the applicant who has already held the drug approval number, import drug registration certificate and pharmaceutical product registration certificate of the drug; the applicant who does not hold the above drug approval documents shall apply for the registration of such new indications at the same time or after submitting the generic drug registration application of the variety. Bohua CPHI pharmaceutical Online

(3) From the date when the new drug enters the monitoring period, the clinical trial application of other applicants with the same variety / modified dosage form but without changing the route of administration will not be accepted; if the clinical application has been approved, the application for production / import registration can be accepted.
(4) For domestic chemical new drugs and imported chemicals applied according to the new drug procedure, the name certificate of the common name of the drug shall be provided when submitting the application for production / import registration.
2、 About generic drug registration application
(5) In accordance with the registration application for Category 6 chemical drugs, the first application shall be made in accordance with the production registration declaration procedures. If the clinical application can be reduced or reduced after evaluation, it can be directly approved for marketing; if the clinical application cannot be reduced or exempted, the clinical trial shall be approved.
(6) If the active ingredients, dosage forms and indications of the declared drugs are the same as those of the marketed drugs, but the specifications, usage and dosage are different, they shall be accepted according to the generic drug procedures.
3、 Application for registration of imported drugs
(7) When applying for re registration of imported traditional Chinese medicine or natural medicine, if the detailed large-scale production process document has not been determined or formed as an appendix of the approval certificate document, the drug evaluation center of the General Administration of the people's Republic of China shall conduct technical evaluation, and in principle, the application shall not be made according to the filing procedure.
4、 About supplementary application

(8) If item 20 of supplementary application for registration of drugs in Annex 4 of the administrative measures for drug registration involves the change of the actual production address of drugs, the applicant shall supplement and provide corresponding research materials in accordance with the technical requirements of "5. Pharmaceutical research data" in the annex "part II production technology transfer" of "provisions on the administration of drug technology transfer registration" (gsyjz [2009] No. 518).
(9) If the main indications and indications of a drug are reduced, it shall be handled in accordance with the procedures and requirements in Item 3 of the supplementary application for registration of drugs in Annex 4 of the administrative measures for drug registration.
(10) If the applicant completes the relevant post marketing technical research according to the requirements of drug approval documents, it shall be handled in accordance with Item 18 of Appendix 4 supplementary registration matters of drugs in the administrative measures for drug registration.
(11) The supplementary application for changing the minimum unit loading of ophthalmic preparations shall be handled in accordance with the procedures and requirements in Item 5 of Annex 4 of the administrative measures for drug registration.
(12) The supplementary application for revocation of a trade name shall be handled in accordance with item 36 of Annex 4 of the administrative measures for drug registration, and shall meet the relevant requirements of the notice on matters related to the cancellation of supplementary application for trade name (sfdbz [2012] No. 130).
(13) If the drug approval certificate has become invalid, the supplementary application for the relevant varieties shall not be accepted.
(14) Supplementary applications for the same product and different preparation specifications shall be accepted one by one according to different preparation specifications.

5、 Related declaration of API and preparation
(15) For the new drug preparation clinical trial application (except category 1.6 and 3.4) and generic drug preparation registration application submitted according to category 1-5 of domestic chemical drugs, the source of API used shall be reviewed during acceptance. If the API used is not approved for marketing, a copy of acceptance notice of API registration application shall be provided, and the acceptance number of relevant API shall be associated, and relevant API and preparation shall be jointly evaluated. When applying for API, relevant information of related preparation manufacturers shall be provided.
Only the application for clinical trial of domestic new drug API (including the imported API applied according to the new drug procedure) is submitted, and the subsequent application for clinical / application production registration of corresponding preparation is not approved. The application for registration of API used in approved imported preparations shall be submitted separately.
(16) If API and preparation are declared according to category 3 and category 5 of chemical drugs, the first application of API and preparation shall be applied according to the new drug clinical registration procedure.
(17) If the API and preparation are declared according to category 3 and category 6 of chemical drugs respectively, class 3 API shall be applied according to the new drug clinical registration procedure. If the approved preparation can be exempted from clinical trials and approved for marketing directly, the drug technical evaluation department shall notify the applicant to supplement other relevant materials required by the application procedures for the marketing registration of API; if the evaluated preparation needs clinical trial, the raw material and preparation shall be approved for clinical trial at the same time. After the completion of the clinical trial, the API shall be declared in accordance with the production registration application procedure.

6、 Others
(18) For the application for clinical trial that has been carried out, relevant materials for clinical trial registration and information publicity according to the requirements of announcement on drug clinical trial information platform (No. 28) shall be submitted at the same time.
(19) In the process of evaluation, if the applicant organization of drug registration application changes its name (subject remains unchanged), contact information (only changes of the applicant's contact telephone number, fax number and e-mail address), registered address (does not change the production address), and the proposed commodity name is added or changed, the original accepting department shall notify the drug technical evaluation department after examination.

    

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