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News - January 10, 2019

EMA Public Consultation on Patient Registries

The European Medicines Agency (EMA) has released for public consultation a discussion paper on the use of patient disease registries for regulatory purposes – methodological and operational considerations. Patient registries are organised systems that use observational methods to collect uniform… read more



News - November 27, 2018

Changes in sight for OMPs and biosimilars in Germany?

The German Ministry of Health recently released a draft bill proposal that would introduce significant changes to the legislation on Orphan Medicinal Products (OMPs) and biosimilars in Germany. The bill, which has yet to pass the Cabinet for approval, sets… read more


News - November 21, 2018

Brexit: Is long-term cooperation on health in jeopardy?

In a letter addressed to Martin Selmayr, European Commission Secretary General, the European health community – patients, researchers, pharmaceutical companies – raised its concerns about the lack of contingency measures specific to the continued collaboration on health and asks for… read more