PRAC recommendations on signals 10 January 2022 All news https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-29-november-2-december-2021-prac-meeting_en.pdf
Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD 7 January 2022 All news https://www.ema.europa.eu/en/documents/other/guidance-electronic-submission-information-investigational-medicinal-products-human-use-extended_en.pdf
Regulating medical devices in the UK 3 January 2022 All news https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
Instructions for Authorization Holders Related to Letters to Healthcare Professionals (DHPC) 31 December 2021 All news Croatia-Instructions-for-MAHs-for-Letters-to-Healthcare-Professionals_03Dec2021-1Télécharger
Guidance on MAH and QPPV location – UK 27 December 2021 All news https://www.gov.uk/guidance/guidance-on-mah-and-qppv-location#history
EMA Management Board: highlights of December 2021 meeting 24 December 2021 All news https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2021-meeting
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021 20 December 2021 All news https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-december-2021
PRAC recommendations on safety signals 14 December 2021 All news https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) 10 December 2021 All news Updated on 30 November 2021
