The recent years have seen a number of high-end innovative therapies becoming accessible to patients in Europe. These products offer groundbreaking new opportunities to patients living with rare diseases or cancer, with the capacity of often one-time disease-modifying and potentially curative treatments. This new generation… read more
EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies submitted its response to the Paediatric and Orphan Medicinal Products (OMPs) inception impact assessment. EUCOPE represents 130 companies, many focused on rare diseases, largely small to medium-sized, playing a key role… read more
Following a successful launch event, the TRANSFORM MEP Interest Group, a multi-stakeholder alliance of Members of European Parliament, patient groups, academia and industry, published two important documents to lay the foundations of an open discussion on key priorities for gene and cell therapies, namely a… read more
Published on 8 December, the European Medicines Agency (EMA) and Heads of Medicines Agency (HMA) Joint Strategy looks into six strategic focus areas: (1) Availability and accessibility of medicines, (2) Digital tools and digital transformation, (3) Innovation, (4) Antimicrobial resistance, (5) Supply chain challenges, and… read more
According to the MHRA Guidance, up until 31 December 2021, medicines can be supplied from Great Britain (GB) to Northern Ireland (NI) with a “pragmatic approach” to applying EU rules on importation and unique identifier requirements. Outside of these two areas, medicines supplied to NI have… read more
Aware of the complex European policy landscape that will keep policymakers busy in the months to come, EUCOPE wanted to discuss the European innovation leadership in the pharmaceutical sector and discover how the European Union and Member States can support pharmaceutical innovation in Europe. On… read more
EUCOPE’s approach to the EU environment for the development of OMPs On 11 August 2020, the European Commission published its evaluation on the legislation for medicines for rare diseases and for children. In November this was followed by an Inception Impact Assessment outlining policy options… read more
EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the European Commission Communication on the Pharmaceutical Strategy for Europe. EUCOPE calls for a comprehensive Pharmaceutical Strategy… read more
In the follow-up of Commission President von der Leyen’s intention to shape a resilient European Health Union, the Commission services announced on 11 November the publication of a Communication on Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats accompanied by… read more
The EU and US Biotech Sector’s Response to COVID-19 On 24 September, EUCOPE, together with BIO, hosted a webinar focusing on the response of the global biotech sector to COVID-19 pandemic as well as measures taken by regulatory and policy institutions in the EU and… read more
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