Product-specific bioequivalence guidance
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
This section includes the European Medicines Agency's (EMA) product-specific bioequivalence guidance, which summarises in a standardised format the relevant study design principles for demonstration of bioequivalence.
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. For more information about product-specific guidance, see:
EMA publishes finalised guidance documents for individual products on a regular basis, once the Committee for Medicinal Products for Human Use has adopted them following a public consultation lasting for a minimum of three months.
If EMA receives comments during the consultation, it publishes an overview of comments with the final guidance documents.
Please refer to the individual guidance documents for their date of coming into effect. Information in product-specific bioequivalence guidance supersedes information previously published on the EMA website covering the same issue, e.g. in European public assessment reports.
Applicants should also consider the clinical pharmacology and pharmacokinetics questions and answers, in conjunction with the corresponding product-specific guidance.
Finalised guidelines
- Abiraterone product-specific bioequivalence guidance
- Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance
- Agomelatine product-specific bioequivalence guidance
- Alectinib product-specific bioequivalence guidance
- Aliskiren product-specific bioequivalence guidance
- Apixaban product-specific bioequivalence guidance
- Asenapine product-specific bioequivalence guidance
- Bosutinib product-specific bioequivalence guidance
- Cabozantinib product-specific bioequivalence guidance
- Capecitabine product-specific bioequivalence guidance
- Carglumic acid product-specific bioequivalence guidance
- Cholic acid product-specific bioequivalence guidance
- Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance
- Crizotinib product-specific bioequivalence guidance
- Dabigatran etexilate product-specific bioequivalence guidance
- Dasatinib product-specific bioequivalence guidance
- Deferasirox product-specific bioequivalence guidance
- Dimethyl fumarate product-specific bioequivalence guidance
- Dolutegravir product-specific bioequivalence guidance
- Dronedarone product-specific bioequivalence guidance
- Elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil product-specific bioequivalence guidance
- Elvitegravir product-specific bioequivalence guidance
- Entecavir product-specific bioequivalence guidance
- Enzalutamide product-specific bioequivalence guidance
- Erlotinib product-specific bioequivalence guidance
- Etonogestrel and ethinylestradiol vaginal delivery system product-specific bioequivalence
- Everolimus product-specific bioequivalence guidance
- Exenatide product-specific bioequivalence guidance
- Ezetimibe product-specific bioequivalence guidance
- Fampridine product-specific bioequivalence guidance
- Fingolimod product-specific bioequivalence guidance
- Gefitinib product-specific bioequivalence guidance
- Ibrutinib product-specific bioequivalence guidance
- Ibuprofen product-specific bioequivalence guidance
- Imatinib product-specific bioequivalence guidance
- Lanreotide acetate product-specific bioequivalence guidance
- Lapatinib product-specific bioequivalence guidance
- Ledipasvir/sofosbuvir product-specific bioequivalence guidance
- Lenalidomide product-specific bioequivalence guidance
- Levodopa/carbidopa/entacapone product-specific bioequivalence guidance
- Levotheroxine product-specific bioequivalence guidance
- Liposomal amphotericin B product-specific bioequivalence guidance
- Lurasidone product-specific bioequivalence guidance
- Memantine product-specific bioequivalence guidance
- Metformin product-specific bioequivalence guidance
- Miglustat product-specific bioequivalence guidance
- Octreotide acetate product-specific bioequivalence guidance
- Olaparib product-specific bioequivalence guidance
- Oseltamivir product-specific bioequivalence guidance
- Palbociclib product-specific bioequivalence guidance
- Paliperidone palmitate product-specific bioequivalence guidance
- Paliperidone product-specific bioequivalence guidance
- Paracetamol product-specific bioequivalence guidance
- Pazopanib product-specific bioequivalence guidance
- Pegylated liposomal doxorubicin hydrochloride product-specific bioequivalence guidance
- Pirfenidone product-specific bioequivalence guidance
- Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance
- Posaconazole product-specific bioequivalence guidance
- Prasugrel product-specific bioequivalence guidance
- Repaglinide product-specific bioequivalence guidance
- Rilpivirine product-specific bioequivalence guidance
- Rivaroxaban product-specific bioequivalence guidance
- Sirolimus product-specific bioequivalence guidance
- Sitagliptin product-specific bioequivalence guidance
- Sorafenib product-specific bioequivalence guidance
- Sunitinib product-specific bioequivalence guidance
- Tacrolimus granules product-specific bioequivalence guidance
- Tadalafil product-specific bioequivalence guidance
- Telithromycin product-specific bioequivalence guidance
- Ticagrelor product-specific bioequivalence guidance
- Ursodeoxycholic acid product-specific bioequivalence guidance
- Vandetanib product-specific bioequivalence guidance
- Vemurafenib product-specific bioequivalence guidance
- Vismodegib product-specific bioequivalence guidance
- Voriconazole product-specific bioequivalence guidance
- Vortioxetine hydrobromide / vortioxetine lactate product-specific bioequivalence guidance
- Zonisamide product-specific bioequivalence guidance