Revision of Guideline on Pharmaceutical Fixed Combination Products

Key changes

Clarification of benefit-risk assessment for combined active substances; alignment with new definitions and terminology in Regulation (EU) 2019/6; updated data requirements for safety and residues documentation.

PV impact

Pharmacovigilance operations and regulatory affairs teams must review the proposed data requirements for combination products. The changes will require more detailed safety evidence in registration packs and potentially more rigorous post-market safety monitoring plans for these products.

Exact policy details

Public consultation start date

24 July 2026

Applies to: The start date for public consultation on the revised guideline.

Start of public consultation · p. 1 · High · Source

Public consultation end date

31 October 2026

Applies to: The deadline for comments from interested parties during the public consultation.

End of consultation (deadline for comments) · p. 1 · High · Source

Expected adoption date of draft revised guideline

Q2 2027

Applies to: Timeline for when the draft revised guideline is expected to be adopted by CVMP.

Expected date for adoption of the draft revised guideline by CVMP for release for consultation · p. 4 · High · Source

Expected end of consultation on draft revised guideline

Q4 2027

Applies to: Timeline for when the consultation on the draft revised guideline is expected to end.

Expected end of consultation on the draft revised guideline · p. 4 · High · Source

Expected date for publication of the revised guideline

Q2 2028

Applies to: When the revised guideline is expected to be published.

Expected date for adoption by CVMP and publication of the revised guideline · p. 4 · High · Source

Workflow rule impacts

Extracted documents

• Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)pdfpdf_text · high · 5 pages