Showing all entries tagged with »regulatory«
December 19, 2022
Based on current discussions by the European Commission, launch conditionalities would not account for the distinct nature of small and mid-sized companies, OMPs and ATMPs. EUCOPE’s Alexander Natz breaks down this aspect of the revision of the General Pharmaceutical Legislation… read more
October 12, 2022
The EU biopharmaceutical ecosystem is currently languishing in third place globally. EUCOPE’s Alexander Natz discusses how the European Commission’s most fundamental review of the pharmaceutical legislation in decades is supposed to change that but in reality, is discouraging innovation and competitiveness…. read more
April 27, 2022
With the European Union’s new Regulation (EU) 2021/2282 on health technology assessment, the evaluation of certain new therapies will now be performed jointly at the European level for the first time. The aims are to speed up access to new… read more
November 20, 2020
Empowering EMA and ECDC, strengthening EU coordination in case of cross-border health threats EUCOPE read with great interest the European Commission’s proposals to build a European Health Union, and we agree that greater coordination across Member States is very much… read more
November 18, 2019
Science and technology in drug development are changing at a fast pace and bring with them a lot of promises. To cope with this evolution, the regulatory environment will need to adapt if it wants to keep with its mission… read more