Medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency 20 May 2022 All news https://www.ema.europa.eu/en/documents/other/monitoring-medical-literature-entry-relevant-information-eudravigilance-database-european-medicines_en.pdf
Questions and Answers Regarding the Implementation of a Risk-Prioritized Periodic Safety Update Report Regulatory Review Pilot (PSUR-RRP) at Health Canada 16 May 2022 All news Canada_QandA_Regarding-the-Implementation-of-a-Risk-Prioritized-PSUR-Regulatory-Review-Pilot-PSUR-RRP-at-Health-Canada-3Télécharger
Australia : Good Clinical Practice (GCP)- inspection program 12 May 2022 All news Australia-Good-Clinical-Practice-GCP-inspection-program_Apr2022-1Télécharger
Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland 9 May 2022 All news Ireland-guide-to-CTs-conducted-under-the-ctr-in-ireland_v3_29APR2022-2Télécharger
PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP 6 May 2022 All news EU-ANNEX-IV-TO-PROCEDURE-FOR-CONDUCTING-GCP-INSPECTIONS-REQUESTED-BY-THE-CHMP_-SPONSOR-AND-CRO_02May2022-2Télécharger
Off-label use: notification by laboratories 2 May 2022 All news France_20220314-demarche-usagenonconforme-guide-entreprises-exploitant-specialites-pharmaceutiques-fevrier-2022_Mar2022-2Télécharger
List of medicines under additional monitoring 29 April 2022 All news EU-List-of-medicines-under-additional-monitoring-_-summary-of-changes_Apr2022-1Télécharger
(China) Key Points for Pharmacovigilance Inspections 25 April 2022 All news https://baipharm.chemlinked.com/news/china-nmpa-announces-key-points-for-pharmacovigilance-inspections
( Spain)Directory of Competent Bodies in matters of Pharmacovigilance of the Autonomous Communities and of the AEMPS 22 April 2022 All news Spain-Directory-of-Competent-Bodies-in-matters-of-Pharmacovigilance-of-the-Autonomous-Communities-and-of-the-AEMPS_04Apr2022-2Télécharger
E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files 19 April 2022 All news https://www.ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files
