EUCOPE has been invited to speak at the next webinar organised by SME Connect, to discuss the needs of and important role played by small and medium-sized companies in the fight against COVID-19. EUCOPE will be represented by Alexander Natz, EUCOPE Secretary General. Other panellists… read more
On the 14 and 15 May, the European Conference on Rare Diseases & Orphan Products (ECRD) will gather patients, academia, research and the industry in a collaborative online dialogue, learning and conversation take place, forming the groundwork to shape future rare disease policies. It is… read more
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
The COVID-19 pandemic creates an extraordinary situation for all stakeholders. EUCOPE members are particularly concerned with the impact the COVID-19 crisis created on clinical development. Delay of patients’ access to innovative treatment The delay caused by the pandemic in drug development is in particular concerning… read more
Following the recent EMA guidance on clinical trials management during COVID-19, EUCOPE calls the EMA and all national authorities to allow for flexibility in these exceptional times. In addition, EUCOPE recommends the following: Standardised Approaches: all stakeholders involved in discussing the COVID-19 response make best… read more
In a study commissioned by EUCOPE, the Office of Health Economics (OHE) assessed the extent to which the Orphan Medicinal Products (OMPs) Regulation (2000/018) has successfully incentivised companies to invest in research and development of OMPs. The study also puts forward an analysis of the… read more
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
The European Commission announced on 25/03/20 that it will work to propose to the postponement of the implementation date of the Medical Devices Regulation (2017/745 – MDR). In light of the fight against COVID-19 and its numerous consequences on the healthcare systems and all actors,… read more
EUCOPE and its member companies are closely monitoring the COVID-19 situation and its potential impact on the manufacturing and distribution of medicinal products. EUCOPE is reporting any expected shortages or distribution problems due to the COVID-19 outbreak and/or current cross-border restrictions put in place by… read more
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
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