EMA publishes four 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 documents have been recently added:

• Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg
• Budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 mg
• Budesonide, prolonged release tablets, 9 mg
• Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg

The new documents will enter into force on 1 September 2025.

The following documents are open for public consultation until 30 April 2025. They are also available on the EMA website under the sub-section “Draft guidelines under consultation”:

• Aprepitant, hard capsules, 80 mg, 125 mg, 80+125 mg and powder for oral suspension 125 mg
• Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5 mg/ml