On 30 November 2020, the Korean Ministry of Food and Drug Safety (MFDS) has issued a press report titled “To Report Drug Adverse Event , Use ‘International Standard Forms’!” as an announcement of an obligation to use the E2B (R3) for electronic transmission of Individual Case Safety Reports (ICSRs) from June 2021, in order to utilize an international standard format when reporting adverse drug reactions.
To help the industry understand the new reporting format, MFDS has revised the “Implementation Guide : Electronic Transmission of Individual Case Safety Reports E2B(R3) Data Elements and Message Specification”.
The main contents of the guideline are standardisation of terms related to adverse drug reactions following international terms, subdividing the reporting items into 260 items, and standardisation of the format of safety reports for clinical trials and post-marketing. The reporter must report in a complete XML file according to the E2B (R3) basic items and Korea-specific items (KR) input conditions (required/non-required values).
Please refer to the following for further information:-
Press Release : 의약품 부작용 보고, ‘국제표준서식’을 활용하세요!
Revised Guide: 「약물이상반응 및 이상사례 전자보고 가이드라인(민원인안내서)」 개정 알림