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
Earlier this Summer the European Commission published its Roadmap for the Pharmaceutical Strategy for Europe which paved the way for a consultation process to which EUCOPE has contributed and will continue engage in the next months. Our position paper accompanying the general consultation is available… read more
Brussels 11 August 2020 – EUCOPE, the European association for small to medium-sized companies in the field of pharmaceuticals, biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the evaluation of EU legislation on Orphan Medicinal Products… read more
EUCOPE, the European association for small to medium-sized companies in the field of pharmaceuticals, biotechnologies – many of which are researching and developing rare disease treatments – notes the publication of the study on the EU Regulation 141/2000 on Orphan Medicinal Products (OMPs) (here below)…. read more
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