EMA Releases Updated Product-Specific Bioequivalence Guidelines for Generics

The European Medicines Agency (EMA) has released finalized product-specific bioequivalence guidelines, now available on its website under the “Product-specific bioequivalence guidance” section. These documents, adopted by the Committee for Medicinal Products for Human Use following public consultation, provide clarity for generic drug applicants across all EU regulatory pathways—centralised, decentralised, mutual recognition, and national procedures. On 30 June and 1 July 2025, the EMA published revised guidelines for several drugs, including acenocoumarol, apixaban, dabigatran, dolutegravir, ibuprofen, levothyroxine, lurasidone, metformin, memantine, oseltamivir, paracetamol, posaconazole, prasugrel, repaglinide, tadalafil, ursodeoxycholic acid, and voriconazole. These updates include dosage-specific bioequivalence recommendations tailored to each formulation. The effective dates, either 1 November or 1 December 2025, are listed in the respective documents. These revisions aim to harmonize regulatory expectations, streamline submissions, and ensure consistent quality and efficacy standards for generic medicines entering the European market.

16-07-2025