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
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
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 implications concerning the need for… read more
On 3 April, the European Commission adopted a proposal to postpone by one year the application of the Medical Devices Regulation (MDR). Following adoption by the European Parliament on 17 April, the proposal was adopted by the Council on 22 April. The amending Regulation 2020/561… read more
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
EUCOPE, together with experts from Ministries, HTA agencies and pharmaceutical companies, will take part in the next FORUM Event in Berlin on 9 July 2020. The seminar will give the opportunity to discuss, inter alia, the priorities of the German Presidency of the EU on… read more
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
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