As readers will be aware, at the end of 2025, the EU institutions agreed the text of the EU Pharma Package: the wholesale change to the pharmaceutical regime in the EU that has been debated for many years. The changes introduce wide ranging amendments that impact rewards and exclusivities, supply chain set up, and procedures for generics and biosimilars. With the text of the new legislation due to be published shortly, questions are being asked about what this means for the legislative framework in the UK. The EU Pharma Package means divergence between the UK and EU is inevitable, and this is likely to have significant implications for the UK market.
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Recent FDA actions offer long-awaited clarity on what constitutes a ‘minor change’ to solid oral OTC dosage forms, providing manufacturers with a clearer pathway for certain modifications while maintaining a measured, incremental approach to innovation. The FDA docket is open until October 3 for comments.
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles for meetings between FDA and meeting requestors.