EU CTR milestone

The Clinical Trials Information System (CTIS) went live on 31-Jan-2022 and following the first year into the transition period, the EU Clinical Trials Regulation (CTR) has now become mandatory for all initial trial applications, which are required to go through CTIS.

EU CTR “quick guide”

The European Commission has published a new document as part of Eudralex Volume 10. This new “quick guide for sponsors” is intended to support compliance with the rules and procedures of the EU Clinical Trials Regulation.

FDA Draft Guidance

The FDA has published a new draft guidance on Externally Controlled Trials, which is the latest addition in the series of documents to support the Agency’s Real-World Evidence (RWE) Program.

Day 0 for Literature ICSRs

The EMA Pharmacovigilance Inspectors Working Group has produced a new Q&A, which presents its interpretation of the requirements regarding Day 0 for ICSRs described in local journals.

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.

SFDA updates GVPs

The Saudi FDA has published a revised version of its Guideline on Good Pharmacovigilance Practices (GVPs), which includes some significant changes to the ICSR reporting rules, amongst others.

Pholcodine

The EMA Safety Committee has concluded that pholcodine-containing medicines should be withdrawn from the EU market due to the risk of anaphylactic reactions to neuromuscular blocking agents (NMBAs).

PV Inspections

Both the Australian Therapeutic Goods Administration (TGA) and the Saudi FDA have published Metrics Reports presenting information about the Pharmacovigilance Inspections performed.