EUCOPE News by Tag — Regulatory

Filtered by Tag: Regulatory

EUCOPE Resources / News / Press Releases - November 25, 2020

EC Pharmaceutical Strategy – Time for a Modern Approach to Value

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

News - April 14, 2020

Q&A Document on Regulatory Expectations during COVID-19

The European Commission, EMA and the European medicines regulatory network have developed a question and answer guidance document on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. You can access the guidance online here https://www.ema.europa.eu/en/news/guidance-regulatory-requirements-context-covid-19-pandemic. The Q&A document includes information on… read more

News - November 18, 2019

EMA Regulatory Science Strategy: Our Proposals

As the European Medicines Agency (EMA) is convening stakeholders (including a EUCOPE delegation) for a two-days workshop to brainstorm on its Regulatory Science Strategy 2025, please read our latest blog piece detailing our priorities and proposals for a more integrated and collaborative regulatory framework.