United Kingdom – Guidance: Send and receive information on adverse drug reactions (ADRs) 6 May 2024 All news https://www.gov.uk/guidance/send-and-receive-information-on-adverse-drug-reactions-adrs
Quick guide – Transitional trials from EudraCT to CTIS (sponsor users) 3 May 2024 All news https://www.ema.europa.eu/en/documents/other/sponsors-guide-transition-trials-eudract-ctis-ctis-training-programme-module-23_en.pdf
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 29 April 2024 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-april-2024
New recommendations to strengthen supply chains of critical medicines 26 April 2024 All news https://www.ema.europa.eu/en/news/new-recommendations-strengthen-supply-chains-critical-medicines
List of medicines under additional monitoring 22 April 2024 All news https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring
Meeting highlights from the PRAC 8-11 April 2024 19 April 2024 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024
Clinical Trials Information System Webinar: Last Year of Transition 16 April 2024 All news https://www.ema.europa.eu/en/events/clinical-trials-information-system-webinar-last-year-transition
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024 12 April 2024 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-april-2024
Providing Regulatory Submissions in Electronic Format: IND Safety Reports – Guidance for industry 8 April 2024 All news USA-Providing-Regulatory-Submissions-in-Electronic-Format_-IND-Safety-Reports_01Apr2024-1Download
Regulatory information – adjusted fees for applications to EMA from 1 April 2024 5 April 2024 All news https://www.ema.europa.eu/en/news/regulatory-information-adjusted-fees-applications-ema-1-april-2024