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Regulatory changes
Legislation that changes the clocks, and what it means in practice for the products you source, launch or buy.
Also in News: Case notes (11) · Guides: Explainers (24) · Prices (7) · Glossary (3)
24 October 2026 · 6 min read
The EU's new data and market exclusivity rules: eight plus one, extensions to earn, and who they apply to
The agreed EU pharmaceutical package keeps eight years of data protection but cuts baseline market protection from two years to one, with one-year extensions that have to be earned and an eleven-year cap. Adopted by the Council in September 2026, awaiting Parliament's vote, and applying only to products filed from late 2028. What changes, what does not, and what it means for generic entry dates.
24 October 2026 · 3 min read
The EU pharmaceutical package: what the reform changes for exclusivity, and when
Politically agreed in December 2025, adopted by the Council in September 2026 and expected to apply from late 2028, the EU's rewrite of its medicines law changes regulatory data protection from 8+2+1 to 8+1 plus earned extensions, widens the Bolar exemption, and reshapes orphan exclusivity. What is settled, what is still to be published, and what it means for products authorised after it applies.
24 October 2026 · 3 min read
The EU HTA Regulation: joint clinical assessments from 2025, and what they change for launch timing
Since January 2025 new cancer medicines and advanced therapies get one EU-level clinical assessment alongside their authorisation; orphan medicines follow in 2028 and all new medicines in 2030. What a joint clinical assessment is and is not, how it fits with national pricing and reimbursement, what it does to the launch calendar, and why it does not touch generics, biosimilars or parallel trade.