Monitoring implementation and adherence to ICH guidelines 27 September 2021 All news https://admin.ich.org/sites/default/files/2021-09/ICHImplementationPublicReport_2021_0909.pdf
NHS – Safety reporting – UK 24 September 2021 All news https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/safety-reporting/
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021 20 September 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-september-2021
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure 13 September 2021 All news https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 30 August – 2 September 2021 6 September 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-30-august-2-september-2021
Artificial intelligence in medicine regulation – EMA 3 September 2021 All news https://www.ema.europa.eu/en/news/artificial-intelligence-medicine-regulation
Australia – Reporting adverse events – FAQ 30 August 2021 All news Australia-FAQ-Reporting-adverse-events-_-TGA_19Aug2021-1Télécharger
Switzerland – Guidance for Industry electronic exchange of ICSRs through ElViS HMV4 27 August 2021 All news Switzerland_Guidance-for-Industry-Electronic-exchange-of-ICSRs-through-ElViS_Jul2021Télécharger
Hong Kong – Guidance for Pharmaceutical Industry – Adverse Drug Reaction Reporting Requirements 23 August 2021 All news Hong-Kong-Guidance_for-Pharmaceutical_Industry_ADR-reporting-requirements-V1_01Aug2021-1Télécharger
