EMA publishes new and updated product-specific Bioequivalence Guidance

The European Medicines Agency (EMA) publishes product-specific guidance for the demonstration of bioequivalence on its website under the heading "Product-specific bioequivalence guidance". The relevant principles for study design can be found there in a standardised format.

The final versions for individual products will be published once they have been adopted by the Committee for Medicinal Products for Human Use after at least three months of public consultation. If the EMA receives comments during the consultation phase, these will be made available for download together with the final guidance documents.

Revised Guidelines

New finalised guidelines of the following substances were published at the end of June 2023:

  • Ibuprofen (Ibuprofen oral use immediate release formulations 200–800 mg product-specific bioequivalence guidance - Revision 1)
  • Paracetamol (Paracetamol oral use immediate release formulations product-specific bioequivalence guidance - Revision 1)
  • Tadalafil (Tadalafil film-coated tablets 2.5 mg, 5 mg, 10 mg and 20 mg product-specific bioequivalence guidance - Revision 2)

A compilation of the comments received during the public consultation is also available.

The date of coming into effect of the new revisions is 01 January 2024.

New Guidelines

The following drafts were made available, also at the end of June:

  • Bosutinib (Bosutinib film-coated tablets 100, 400 and 500 mg product-specific bioequivalence guidance)
  • Fampridine (Fampridine prolonged-release tablet 10 mg product specific bioequivalence guidance)
  • Lurasidone (Lurasidone film-coated tablets 18.5, 37 and 74 mg product-specific bioequivalence guidance)
  • Metformin (Metformin immediate-release film-coated tablets 500, 850 and 1000 mg product-specific bioequivalence guidance)
  • Pirfenidon (Pirfenidone film-coated tablets 267, 537 and 801 mg, and hard capsules 267 mg product-specific bioequivalence guidance)

Comments on these new draft guidelines can be submitted until 30 September 2023.

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