EU-MedDRA companion ptc_Oct2020

https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures-in-the-event-from-1-january-2021/updated-guidance-on-pharmacovigilance-procedures

Due to COVID-19 pandemic and  the recent announcement of the French government of a second national lockdown, we have activated our business continuity plan and we have deployed our 100% remote-work model. Our team have the necessary resources available to…

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-october-2020

EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its October 2020 meeting.

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.