EMA publishes new Product-Specific Bioequivalence Guidance

The European Medicines Agency (EMA) has published new finalised product-specific bioequivalence guidelines on its website under the section "Product-specific bioequivalence guidance"

The EMA regularly publishes finalised guidance documents for individual products after they have been adopted by the Committee for Medicinal Products for Human Use, following a public consultation lasting a minimum of three months. Product-specific guidance helps applicants meet the expectations of regulators in the European Union, particularly for generic applications, across all regulatory submission routes, i.e. via the centralised, decentralised, mutual recognition or national procedures.

The following revised guidance documents were published on 30 June and 1 July 2025, respectively:

• Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - Revision 1
• Apixaban film-coated tablet 2.5 and 5 mg product-specific bioequivalence guidance - Revision 1
• Dabigatran etexilate hard capsule 75 mg, 110 mg and 150 mg product-specific bioequivalence guidance - Revision 1
• Dolutegravir film-coated tablets 10 mg, 25 mg and 50 mg product-specific bioequivalence guidance - Revision 1
• Ibuprofen oral use immediate release formulations 200 - 800 mg product-specific bioequivalence guidance - Revision 2
• Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg and 200 mcg (and additional strengths within the range) product-specific bioequivalence guidance - Revision 1
• Lurasidone film-coated tablets 18.5, 37 and 74 mg 4 product-specific bioequivalence guidance - Revision 1
• Metformin immediate-release film-coated tablets 500, 850 and 1000 mg and 1000 mg/5ml oral solution product-specific bioequivalence guidance - Revision 1
• Memantine film-coated tablets 5, 10, 15 and 20 mg, oral solution 5 mg product-specific bioequivalence guidance - Revision 1
• Oseltamivir hard capsules 30, 45 and 75 mg, powder for oral suspension 6 mg/ml and 12 mg/ml product-specific bioequivalence guidance - Revision 1
• Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 2
• Posaconazole oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1
• Prasugrel film-coated tablets 5 mg and 10 mg product-specific bioequivalence guidance - Revision 2
• Repaglinide tablets 0.5, 1 and 2 mg product-specific bioequivalence guidance - Revision 1
• Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 3
• Ursodeoxycholic acid capsule 250 mg, film-coated tablet 150 mg, 300 mg, 450 mg, 500 mg, 600 mg and suspension 50mg/ml (250mg/5ml) product-specific bioequivalence guidance - Revision 1
• Voriconazole tablets 50, 200 mg and powder for oral suspension 40 mg/ml product-specific bioequivalence guidance - Revision 1

The respective effective date (either 1 November or 1 December 2025) is indicated in the individual guideline documents.