In the past two decades, a combination of scientific breakthrough coupled with strong incentives systems brought about great progress for rare disease patients. The number of medicines approved in Europe to treat rare diseases since 2000 increased from 8 to 169. However, with 95% of… read more
On the verge of the publication of the EU industrial strategy in March, EUCOPE shared the expectations and ambitions of its membership for a coherent strategy that harness Europe’s untapped potential: small and medium biopharma. The mission letter from President von der Leyen to Commissioner Kyriakides… read more
EUCOPE, together with other European pharmaceutical trade associations, wrote a letter to the presidents of the Commission, Council and Parliament, as well as Trade Commissioner Phil Hogan and the EU’s chief negotiator Michel Barnier, voicing our shared concern about the lack of progress within the… read more
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 and support EU industry to… read more
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 or life-limiting conditions but also… read more
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 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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