The EU Council adopted its negotiating position on the first major overhaul of pharmaceutical legislation since 2004. The package targets faster access, competitiveness and incentives (notably for antimicrobials), alongside obligations on supply continuity and environmental risk.
Why it matters for API trade
• Stronger expectations for shortage prevention plans and notification lead‑times.
• Potential impact on data exclusivity and incentives could affect portfolio priorities.
• Growing attention to green manufacturing and ERA data from API sites.
