The Clinical Trials Regulation (EU) 536/2014 was implemented to harmonise the process of conducting and monitoring clinical trials across the European Union (EU) whilst simultaneously improving transparency. The December 2020 CTIS highlights newsletter covers the key features and future developments in the CTIS. Read more “EMA publishes second issue of their Clinical Trials Information System (CTIS) Highlights newsletter”
Category: Industry news
The latest news from the Pharmaceutical Industry
MHRA reveal new Brexit guidance on QPPV and PSMF requirements
As of 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) have published new guidance on the qualified person responsible for pharmacovigilance (QPPV) and the pharmacovigilance system master files (PSMF) for existing marketing authorisation holders (MAH) in the United Kingdom (UK) in light of Brexit. Read more “MHRA reveal new Brexit guidance on QPPV and PSMF requirements”
EU Regulators publish joint network strategy for the next five years
The European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) have adopted their joint network strategy to 2025. Read more “EU Regulators publish joint network strategy for the next five years”
The European Commission’s new pharmaceutical strategy
The European Commission (EC) has adopted its new pharmaceutical strategy for Europe, highlighting support for innovation, research and development. Read more “The European Commission’s new pharmaceutical strategy”
European Commission strategy for effective COVID vaccine rollout
The European Commission (EC) has laid out key steps in a strategy for effective COVID-19 vaccine deployment in Member States (MS). Read more “European Commission strategy for effective COVID vaccine rollout”
‘Brexit Readiness Checklist’ for companies doing business with the UK
The European Commission (EC) has published a Brexit Readiness Checklist in anticipation of the end of the transition period on 1 January 2021. Read more “‘Brexit Readiness Checklist’ for companies doing business with the UK”
Stockpiling drugs in anticipation of the end of Brexit Transition
The UK government has written an open letter to medicine suppliers, outlining how supply can be maintained in anticipation of the end the Brexit transition period on 31 December 2020. Read more “Stockpiling drugs in anticipation of the end of Brexit Transition”
Highlights from the July CHMP meeting 2020
From their meeting in July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. Read more “Highlights from the July CHMP meeting 2020”
Find out about the latest MDR implementation updates
The European Commission (EC) have recently provided several updates on the implementation of the Medical Device Regulation (MDR). Read more “Find out about the latest MDR implementation updates”
Did you know that the EMA have a new Executive Director?
The European Medicines Agency (EMA) have nominated Emer Cooke as their new Executive Director. Read more “Did you know that the EMA have a new Executive Director?”