EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its October 2020 meeting.
EMA’s safety committee (PRAC) has started a review of a safety signal to assess reports of acute kidney injury in some patients with COVID-19 taking Veklury (remdesivir). Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September – 1 October 2020
USA- FDA guidance on conduct of CT during Covid-19_updated 01Sep2020
EU- IME list inclusion-exclusion criteria_11Sep2020
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2020 meeting.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets from 1 January 2021.
This guidance sets out how the MHRA will handle centralised applications that are still pending on 1 January 2021.
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.