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 8, 2020
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
EUCOPE Resources / News - April 6, 2020
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
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 - March 19, 2020
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
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 - September 26, 2019
The Czech Ministry of Health recently announced that the Public Health Insurance Act 48/1997, which regulates the scope and conditions under which health services are covered as well as their pricing and reimbursement, would be amended. The foreseen amendments, expected to enter into force in… read more
News - September 12, 2019
Earlier this month, the Maltese Deputy Prime Minister and Minister for Health, Mr Chris Fearne, met with EUCOPE to discuss issues pertaining to transparency and access to medicines. This meeting took place against the background of the ongoing activities of the Valetta Declaration – which,… read more
News - February 8, 2019
As of 9 February 2019, most prescription medicines supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. These mandatory safety features are implemented through a delegated regulation that comes into application… read more
