What "Made in Europe" will mean for critical medicines

The European Union's Critical Medicines Act has reached the point where its obligations can be read rather than inferred. The European Commission proposed the regulation in March 2025. The Council agreed its negotiating position on 2 December 2025, and the European Parliament adopted its own position in January 2026.

Negotiators struck a provisional agreement in the early hours of 12 May 2026, under the Cyprus presidency, after more than 12 hours of talks. The Permanent Representatives Committee endorsed the final compromise on 30 June, and the Council published the consolidated text the same day as an annex to a letter sent to the chair of Parliament's public health committee.