Clinical trials for medicines: manage your authorisation, report safety issues – UK
Update: Added guidance on how to increase transparency when presenting safety information in the Development Safety Update Report (DSUR)
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 July 2021
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-july-2021
ANSM – Application for early access authorization
https://ansm.sante.fr/vos-demarches/industriel/demande-dautorisation-dacces-precoce
SwissMedic – Clinical trials on medicinal products
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/clinical-trials/clinical-trials-on-medicinal-products.html
AEMPS – Information on risk prevention
https://www.aemps.gob.es/medicamentos-de-uso-humano/farmacovigilancia-de-medicamentos-de-uso-humano/informacion-sobre-prevencion-de-riesgos/?lang=en
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 June 2021
Eight new medicines recommended for approval.
Providing Regulatory Submissions in Electronic Format — Standardized Study Data – Guidance for Industry
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-standardized-study-data
Highlights of Management Board: June 2021 meeting
https://www.ema.europa.eu/en/news/highlights-management-board-june-2021-meeting
Guide on how to report suspected Reactions Adverse directed to promoters of studies observational drugs for use Human, not Marketing Authorisation Holders
https://www.aemps.gob.es/investigacionClinica/medicamentos/docs/instrucciones-notificar-promotor-EPA-no-TAC2.pdf?x54046