EU Publishes Updated Pharmaceutical Legislation Text
What happened
EU institutions published updated text on the reform of EU pharmaceutical legislation, including a new Directive and Regulation, on October 8, 2026. This publication follows a provisional political agreement reached on December 11, 2025, and votes in March 2026. The new standard sets Regulatory Data Protection at nine years, consisting of eight years of RDP and one year of Market Protection.
From mondaq.com
Why it matters
The updated text establishes a nine-year standard for Regulatory Data Protection, which affects market exclusivity for medicines. Additional one-year periods of Market Protection may be granted if a product addresses an unmet medical need or meets specific criteria related to new active substances and clinical trials.
The MDR/IVDR reforms require formal adoption by the European Parliament, referencing US FDA pre-submission meetings.
From mondaq.com
Who's involved
- European CommissionPublished the updated text on the reform of EU pharmaceutical legislation.
- European ParliamentMust formally scrutinize and approve the legislation alongside the Council.
- Council of the European UnionMust formally review and endorse the legislation alongside the Parliament.
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The entities involved
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European Commission
executive branch of the European Union
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European Parliament
parliament of the European Union directly elected by the citizens of the Union
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