Showing all entries tagged with »regulatory«
August 24, 2023
In this article, Michael N. Abrams and Alexander Natz discuss the current policy initiatives from Europe and the U.S., similarities between them, and implications for the pharmaceutical sector and their standing in a competitive global market. For years, lawmakers have… read more
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