News - June 16, 2020
The European Commission just opened the public consultation on its proposed pharmaceutical strategy for the EU. In the Commission’s words, the strategy intends to ‘address the current issues of access, availability and affordability of medicines, while still promoting sustainable innovation… read more
News - June 2, 2020
EUCOPE examined with great interest the European Commission’s Pharmaceutical Strategy Roadmap. We welcome the European Commission’s acknowledgement of the crucial role played by the pharmaceutical sector in the economy of the EU, as well as the creation of a future-proof,… read more
News - May 29, 2020
As part of the collective response to COVID-19, a significant number of clinical trials are underway in an attempt to identify potentially effective COVID-19 treatments and bring them rapidly to patients. The EMA has published guidance documents on EMA initiatives… read more
News - May 15, 2020
The 10th European Conference on Rare Diseases (ECRD), the largest patient-led event on rare diseases and orphan products, presented an excellent opportunity for exchange among the patient community and experts from various backgrounds. The conference allowed EUCOPE to share the… read more
News - May 6, 2020
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury, bringing with them the promise of treatment of severe, disabling… read more
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… read more
News - April 28, 2020
The European Centre for Disease Control (ECDC) published an interesting list of questions and answers in relation to the COVID-19 pandemic. The Q&A list, available on their website covers many topics from general information, medical information, prevention, to more practical… 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… 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… 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… read more
