Phacilitate Leaders Forum

15th – 16th October 2019

Kerry Hotel Pudong, Shanghai

Announcement No.23 (2018) of the State Drug Administration of China and the State Health Commission of China

Announcement No.23 (2018) of the State Drug Administration of China and the State Health Commission of China

This Announcement is hereby made with regard to the relevant matters involved for implementing the Guidelines of the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council of China on Deepening the Reform of the System of Review, Examination and Approval and on Encouraging the Innovation of Drugs and Medical Equipment [Serial No.: G.O. 42 (2017)] and the Guidelines of the State Council of China on Reforming the System of Evaluation, Examination and Approval Related to Drugs and Medical Equipment [Serial No.: S.C. 44 (2015)] and for improving the efficiency of examining and approving the marketing of innovative drugs and scientifically simplifying the examination and approval procedures.

It is imperative to further implement giving priority to the evaluation, examination and approval of drugs. With regard to drugs for the treatment and prevention of life-threatening diseases without pre-existing effective treatments, the Center for Drug Evaluation (CDE) of the State Administration of Food and Drug Supervision will set up a mechanism for communication with the applicant. This will strengthen the guidance for drug research and development and will give priority to the processing of registration applications that have been confirmed as eligible for being granted priority review, accelerating examination and approval.

With regard to overseas marketed drugs for preventing and treating diseases which seriously threaten the lives of the patients but for which there are still no effective means of treatment and drugs for preventing and treating rare diseases, the applicant for registering such imported drugs who, upon the necessary research, believes that there exists no difference between races may submit the clinical trial data obtained overseas to apply for the registration of the said drugs directly.

With regard to applications which have been accepted before this announcement is made for conducting clinical trials of the aforementioned imported drugs and which request the reduction or exemption of the clinical trial - if such applications conform to the requirements as enumerated in the Measures for the Administration of Drug Registration and in other related documents, the importation of such drugs may directly be approved.

It is imperative to conduct drug inspections in view of the need to ensure product safety and control possible risks. After an application for the clinical trial of drugs is accepted, if the CDE, upon evaluation, deems it necessary to conduct such inspections, it shall put forward the inspection requirements and inform the applicant to provide a test report on the clinical trial samples by the applicant himself or herself or by an inspection agency within the prescribed time; if the CDE, upon evaluation, deems it unnecessary to conduct such inspections, it shall not inform the applicant of the need to conduct such inspections.

With regard to an application accepted prior to December 1, 2017 for conducting drug clinical trials, if the CDE, upon evaluation, deems it unnecessary to conduct such trials, it shall inform the relevant inspection agency to terminate the trial and shall continue the process for the review, examination and approval of said application.

In the event that the relevant inspection agency has drawn a test conclusion which does not conform with the provisions of the relevant regulations, the CDE shall not grant approval to the application.

The procedures for the re-registration of imported drugs and for the verification of the related files shall henceforth be rescinded. After an application for the re-registration of imported drugs has been accepted, all the relevant data shall be transferred to the CDE for examination and approval.

All applications for re-registration of imported drugs which have been accepted before this announcement is made, including import re-registration applications whose file verification by the relevant authorities has proved that there is no need to re-examine the quality standard of the imported drugs, shall uniformly be transferred to the CDE for review, examination and approval.

Adjustment is hereby made so that the administrative decision currently made by the State Drug Administration of China on the examination and approval of the various types of temporary drug imports shall henceforth be made by the CDE in the name of the State Drug Administration of China.

New numbering rules shall be implemented for the Registration Certificate for Imported Drugs and the Registration Certificate for Medical Products. After applications for the re-registration of imported drugs or relevant supplementary applications have been approved, they shall not be renumbered.