Safety Observer 196
The US FDA has published the final guidance entitled “Format and Content of a REMS Document”.
Report 196 — Highlights
EU Clinical Trial Regulation
The Clinical Trials Information System (CTIS) went live on 31-Jan-2022 and after a year into the transition period, all initial trial applications will be required to go through CTIS from 31-Jan-2023. The EMA will hold a meeting on 20-Jan-2023 to prepare for the mandatory use of the EU Clinical Trial Regulation (CTR).
FDA REMS guidance
The FDA has published the final guidance entitled “Format and Content of a REMS Document”, which describes the format for a REMS (Risk Evaluation and Mitigation Strategy) document.
FDA DSUR
The FDA has issued a proposed rule that would require the annual submission of a DSUR (Development Safety Update Report) instead of the current IND Annual Report.
Canada regulations
Health Canada has launched a consultation on the modernization of its regulations. One of the topics concerns the requirement to submit RMPs (Risk Management Plans) for higher-risk products.
