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.
Close consideration should be given to this Q&A on when an additional bioequivalence study with concomitant treatment with an acid-reducing agent is needed to show bioequivalence in the cases where a generic product uses another salt/API form or different pH modifying excipient/technology than the reference product.