Clinical trials for medicines: apply for authorisation in the UK
https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk#full-publication-update-history
Changes to the guidance document Temporary authorisation of human medicinal products HMV4
https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-befristete-zulassung-ham.html
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 13 January 2022
Meeting highlights from the PRAC 10 – 13 January 2022
Pharmacovigilance Inspection Metrics April 2020 to March 2021 – MHRA
Pharmacovigilance Inspection Metrics April 2020 to March 2021 – MHRA
PRAC recommendations on signals
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
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
https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
Guidance on MAH and QPPV location – UK
https://www.gov.uk/guidance/guidance-on-mah-and-qppv-location#history
EMA Management Board: highlights of December 2021 meeting
https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2021-meeting