This guidance contains information about registration of clinical trials, publishing trial results and future requirements from 1 January 2021.
Pharmacovigilance system requirements from 1 January 2021
This guidance summarises the Medicines and Healthcare products Regulatory Agency’ (MHRA) approach to pharmacovigilance from 1 January 2021.
Pre-authorisation guidance posted by the European Medicines Agency’s (EMA) on 18 August 2020.
France- clinical trials and COVID 19_ Q&A updated Aug 2020
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals
The framework changes the procedure for submitting periodic benefit-risk assessment reports and the analysis by the Agency’s sector dealing with pharmacovigilance. The frequency of presentation of reports, for example, will be carried out by a list published here, on the…
https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-11-14-may-2020-prac_en.pdf
https://www.ema.europa.eu/en/documents/other/new-product-information-wording-extracts-prac-recommendations-signals-adopted-11-14-may-2020-prac_en.pdf
https://mhrainspectorate.blog.gov.uk/2020/08/03/gcp-serious-breaches-update/