CDE emergency: the delayed submission of API application materials has affected the review progress. Please read the new requirements quickly!

On January 13, CDE issued a notice on matters related to the application materials of chemical APIs, which pointed out that at present, some applicants have delayed submission of application materials of APIs, which has affected the review progress In order to ensure the integrity of the materials and improve the review efficiency, it was once again clarified that when submitting the application, the applicant for registration of pharmaceutical preparations should strictly follow M4: application for registration of human drugs Please submit complete application materials as required by the general technical document (CTD) or the circular on the requirements of issuing the application materials for new registration and classification of chemicals (Trial) (No 80, 2016) In addition, for the original supplementary package that cannot be registered on the platform due to special reasons, the original supplementary package research data can also be provided by the drug preparation registration applicant together with the drug preparation registration application The following is the original text of the notice: according to the requirements of the announcement of the State Food and Drug Administration on further improving matters related to the review, approval and supervision of Drug Association (No 56, 2019), for the original auxiliary package that cannot be registered on the platform due to special reasons, the original auxiliary package research data can also be provided by the applicant for drug preparation registration when applying for drug preparation registration At present, some applicants have the situation that the delayed submission of some application materials for APIs has affected the review progress In order to ensure the integrity of the materials and improve the review efficiency, it is clarified again that when submitting the application, the applicant for registration of pharmaceutical preparations should strictly follow M4: General technical document for registration of human drugs (CTD) or application materials for new registration of chemical drugs Notice of material requirements (Trial) (No 80, 2016) requires to submit complete application materials Notice is hereby given Drug evaluation center of State Drug Administration