US EditionAgreement Reached on EU's New Pharma Legislation
The EU deal includes an 8-year baseline data protection and incentives for antimicrobials to improve access, innovation, and supply security, pending formal approval.
- On Dec. 11, 2025 the European Council and European Parliament reached a political agreement to revise EU pharmaceutical law, marking the first major update in 20 years, pending formal approval.
- Proposed in 2023 by the European Commission, the overhaul follows warnings earlier this year from pharma leaders about losing R&D and capital to the US without stronger reforms.
- A streamlined regulatory framework will simplify EMA procedures by reducing scientific committees from five to two, cutting review time from 210 to 180 days, and enforcing electronic common-format filings.
- NGOs and patient advocates cautioned that negotiators largely preserved existing data protections and left gaps on cost reductions and access, despite the EU pharmaceutical reform being called a 'historic milestone' by the EMA and Várhelyi stating `will redefine this sector for decades to come`.
- The package aims to improve patient access, tackle antimicrobial resistance, reduce shortages and raise environmental standards across the EU, while supporting new therapies for unmet medical needs, orphan and paediatric medicines.
12 Articles
12 Articles
Deal on comprehensive reform of EU pharmaceutical legislation - The European Sting - Critical News & Insights on European Politics, Economy, Foreign Affairs, Business & Technology - europeansting.com European Union News
(Credit: Unsplash) This article is brought to you in association with the European Parliament. Promoting innovation and increasing access to medicinal products across the EU Combatting antimicrobial resistance Optimising European Medicines Agency’s structure and simplifying regulatory procedures Improving monitoring and management of shortages Early morning on Thursday, co-legislators reached a provisional agreement on revamping the EU’s p…
EU forges deal over major pharma legislative changes
The European Council and Parliament on Thursday said that they reached agreement on a new set of pharmaceutical industry reforms — the first in more than two decades. But an industry group argues the deal will not make the EU’s pharma sector more competitive.
Coverage Details
Bias Distribution
- 100% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
