Notice of the Center for Drug Evaluation of NMPA on the Applicability of E2B (R3) Regional Implementation Guide to Individual Case Safety Reports during Drug Clinical Trials
In order to implement the E2B (R3) Regional Implementation Guide for Individual Case Safety Reports (hereinafter referred to as the Regional Implementation Guide), the Center for Drug Evaluation has completed the upgrade of the pharmacovigilance system during clinical trials, which was put into trial operation on January 1, 2022. Applicants shall complete the system configuration in a timely manner, and implement E2B (R3) in accordance with the Regional Implementation Guide no later than July 1, 2022.
Regional field test requirements:
I. Users who have previously passed the test
The users who have previously passed the test shall generate a test ICSR in XML format that meets the requirements of the Regional Implementation Guide and email it to E2Btest@cde.org.cn, with the email subject indicating "Application for China regional field test of E2B (R3)-enterprise name"; the email text shall provide the sponsor name and the unique ID of the enterprise (N.2.r.2), and list the specific regional fields tested and the allowable values.
II. Users who have not passed the test yet
The users who have not passed the test yet shall apply for the test on the basis of meeting relevant requirements in the Standard and Procedure for Rapid Reporting of Safety Data during Drug Clinical Trials and with reference to the above test requirements.