Final text of the Pharma Package published

The final drafts of the proposed Directive and proposed Regulation have been published. The revised texts reflect the revisions proposed by the Council and the European Parliament and related compromise provisions. Formal adoption of the provisions is anticipated for late June or early July 2026 with a subsequent two-year transition period during which they will enter into application.

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EDPB-EDPS JOINT OPINION 3/2026 on the proposed European Biotech Act

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MHRA Field Safety Notices – Guidance for Manufacturers