EUCOPE News — Commission
Press Release - January 7, 2021
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… read more
Tags: Commission, Medicines, OMP, Rare Diseases
News - December 1, 2020
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… read more
Tags: Commission, Medicines, OMP, Patients, Rare Diseases
News / Press Release - November 25, 2020
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… read more
Tags: Access, ATMPs, Commission, COVID19, Medicines, OMP, Patients, Rare Diseases, Regulatory, Research
News - November 24, 2020
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… read more
Tags: Commission, Medicines, Patients
News - June 16, 2020
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… read more
Tags: Commission, Medicines, OMP, Patients
News - November 7, 2019
With 6 months to go before the application of the Medical Devices Regulation (MDR), the European Commission is putting pedal to metal in the implementation process! Two new Notified Bodies have indeed been recently designated to operate under MDR from… read more
Tags: Commission, Medical Devices, Safety
News - August 14, 2019
The European Commission just published a FAQ document on the new Unique Device Identification (UDI) system, as introduced by the two new Regulations on Medical Devices (2017/745) and In Vitro Diagnostics Devices (2017/746). The document spells out the objectives of… read more
Tags: Commission, IVDR, MDR, Medical Devices, Patients