Primary source: European Medicines Agency (EMA)
A public consultation has been initiated for a revision of the guideline on pharmaceutical fixed combination products, with comments accepted from 24 July 2026 until 31 October 2026.
This revision is crucial for ensuring compliance with updated regulatory requirements and for improving the quality of applications for combination products.
Regulatory Affairs teams must review the proposed data requirements and prepare for more rigorous documentation in registration applications and post-market monitoring.
Regulatory Intelligence Lead
Review before 2026-10-31.
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.
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.
The guideline revision may require updates to compliance protocols regarding fixed combination products.
Revision of the guideline to incorporate current scientific and regulatory requirements.
Regulatory Affairs teams must review the proposed data requirements and prepare for more rigorous documentation in registration applications and post-market monitoring.
The EMA is updating the guideline on pharmaceutical fixed combination products to align with Regulation (EU) 2019/6, clarifying data requirements for efficacy, safety, and residues. Key changes include more detailed safety evidence in registration packs and enhanced post-market monitoring plans.
What changed: A public consultation has been initiated for a revision of the guideline on pharmaceutical fixed combination products, with comments accepted from 24 July 2026 until 31 October 2026.
Why it matters: This revision is crucial for ensuring compliance with updated regulatory requirements and for improving the quality of applications for combination products.
Practical implication: Regulatory Affairs teams must review the proposed data requirements and prepare for more rigorous documentation in registration applications and post-market monitoring.
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