EMA: Public Consultation of Annexes to ICH Q3C and VICH GL18 on Residual Solvents
The European Medicines Agency (EMA) has published revised annexes to the ICH Q3C guideline (“Impurities: Guideline for Residual Solvents”) and the corresponding veterinary guideline VICH GL18 for public consultation. The commenting period is open until the end of June 2026.
The revision aims primarily to align the annexes with the latest version of the ICH Q3C guideline (up to Revision R9) and to further harmonise requirements between human and veterinary medicinal products. In addition, the update addresses practical challenges and ambiguities observed in regulatory assessment and inspections.
The changes concern Annex I only, while Annex II remains unchanged. A key new feature is the introduction of decision trees, intended to provide structured guidance on the control of residual solvents. These are designed to support consistent decision-making regarding when testing is required, when specifications need to be established, and how appropriate control strategies can be justified.
Furthermore, the revised annex includes more explicit expectations regarding the management of manufacturing changes, such as changes in starting materials, suppliers, or process parameters. In such cases, a more systematic assessment of the impact on residual solvents is required, including, where appropriate, revalidation activities.
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