News - May 5, 2020
The European Medicines Agency has published an overview of how it will accelerate its regulatory procedures so that the marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures will be able to accelerate every… read more
News - May 4, 2020
On 27 and 28 May, EUCOPE and Drug Information Association (DIA) jointly organise an online workshop on ATMPs and Innovative Gene and Cell Therapies. The event is a unique opportunity to hear directly from the Industry and Regulatory representatives about the challenges, opportunities and political… read more
News - April 28, 2020
The European Commission, EMA and the national competent authorities have agreed on a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the European Union. The… read more
News - April 14, 2020
The European Commission, EMA and the European medicines regulatory network have developed a question and answer guidance document on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. You can access the guidance online here https://www.ema.europa.eu/en/news/guidance-regulatory-requirements-context-covid-19-pandemic. The Q&A document includes information on… read more
News - April 3, 2020
The European Medicines Agency (EMA) recently issued a new guidance following the COVID-19 outbreak, to help clinical trials sponsors in adjusting their management of trials and participants during the pandemic. The guidance covers how to deal with, for example, the self-isolation or quarantine of trial participants,… read more
News / Press Releases - March 10, 2020
EUCOPE asks the European Commission to put research at the heart of its Pharmaceutical Strategy The European Commission’s Pharmaceutical Strategy for Europe must: Provide ambitious measures to foster research in rare diseases and other disease areas for which we currently have no cure. Harness the… read more
News - November 18, 2019
As the European Medicines Agency (EMA) is convening stakeholders (including a EUCOPE delegation) for a two-days workshop to brainstorm on its Regulatory Science Strategy 2025, please read our latest blog piece detailing our priorities and proposals for a more integrated and collaborative regulatory framework.
News - March 27, 2019
Following the last Medical Devices Coordination Group (MDCG)-Stakeholders’ meeting of 14 February, the European Commission (EC) updated the ‘Rolling Plan’ containing the list of essential implementing acts and actions for the transitional period as well as information on expected timelines and state-of-play of the coming… read more
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