Product-specific bioequivalence guidance
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:
- Concept paper on development of product-specific guidance on demonstration of bioequivalence (EMA/CHMP/423137/2013) .
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.
Any stakeholder can comment on the draft guidelines under public consultation by completing the form for submission of comments on scientific guidelines and emailing their comments to email@example.com.
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 follow any subsequent guidance of the Pharmacokinetics Working Party, including its questions and answers, in conjunction with the corresponding product-specific guidance.
Draft guidelines under public consultation