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
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
On 30/11, the European Medicines Agency (EMA) will organise a virtual event to encourage early and efficient interactions with the regulators by highlighting pre-marketing support in medicine development in rare diseases. The meeting will highlight and explain existing tools in the context of early product development strategy…. 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
Sickle cell disease is one of the most prevalent genetic diseases in Europe. A recent report, commissioned by our member company Global Blood Therapeutics, use the latest data from 5 EU countries to draw recommendations to improve the life expectancy of people living with this… 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
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
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