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 (CHMP) has adopted them following a public consultation. 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.
If you have comments on a document that is open for consultation, use the form for submission of comments on scientific guidelines.
A questions-and-answers document is available on specific questions addressed to the Pharmacokinetics Working Party (PKWP) in relation to pharmacokinetic evaluations, which should be read in conjunction with the relevant scientific guidelines:
- Questions & Answers: positions on specific questions addressed to the Pharmacokinetics Working Party
Draft guidelines under public consultation
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