Bioequivalence meaning

In this issue: Intellectual property Post-market Competition in life sciences Commercialisation Data protection and life sciences Advanced therapeutics Pharmaceuticals—regulatory framework Research and development Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Patenting AI innovations in healthcare—navigating European patent law Jack Severs (partner) and Joe Spencer (associate) of Gill Jennings & Every LLP explore what is considered patent-eligible in European AI healthcare. See News Analysis: Patenting AI innovations in healthcare—navigating European patent law. Dapagliflozin—UK court reaffirms plausibility standard despite G 2/21 In Generics (UK) Ltd v AstraZeneca AB, the High Court of England and Wales delivered a thorough restatement of the UK tests for inventive step and sufficiency, anchored in the idea of ‘plausibility’. Ian Jones, partner at Gill Jennings & Every LLP, assesses the ruling. The judgment in Generics (UK) Ltd v AstraZeneca AB [2025] EWHC 1012 (Pat) underscores the UK’s growing departure...

C–D | E–H | I–N | O–P | Q–V. Accelerated assessment Many countries provide a regulatory route that speeds up the appraisal of certain medicinal products, helping them reach patients sooner. In the EU, this accelerated assessment significantly shortens the period for the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to examine a marketing authorisation (MA) application from 210 to 150 evaluation days overall. An application can be considered for this pathway where the CHMP judges the product to be of major relevance for public health and therapeutic innovation. See Practice Note: Marketing authorisations in the EU—regulatory procedures for approval of medicinal products—EU centralised authorisation procedure. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) provides a 150-day review for all high‑quality new MA applications to hasten equitable access to new medicines for UK patients. The MHRA assesses applications for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland MA and delivers its considered view on whether to grant...