The European Medicines Agency (EMA) has published a revision of the annexes to the ICH Q3C and VICH GL18 guidelines on residual solvents in medicinal products, providing updated specifications for controlling class 1 and class 2 solvents in active substances and finished products. The revision, adopted by the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) in 2026, is open for public consultation until June 2026 and will impact pharmaceutical manufacturers, regulators, and quality control laboratories.
The document, released on 29 April 2026, amends the annexes to the ICH Q3C guideline (EMA/CHMP/ICH/82260/2006) and the VICH GL18 guideline (EMA/CVMP/VICH/502/1999). It clarifies when routine testing for residual solvents can be omitted or replaced by skip testing based on the solvent's use in manufacturing steps and accompanying risk assessments. For class 1 solvents, routine control is required if they are used in the last manufacturing step; if used earlier, control may be performed at intermediate stages or omitted entirely if levels are demonstrated to be below 10% of the permitted limits. For class 2 solvents, testing can be omitted if levels are below 10% of the acceptable limits. The revision also addresses testing requirements for finished products, mandating testing unless only class 3 solvents are used.
Policy orientations and trade-offs The revision balances regulatory oversight with manufacturing flexibility. By allowing skip testing and omission of routine control under specific conditions, the EMA reduces the compliance burden on manufacturers, potentially lowering production costs and accelerating time-to-market. However, this flexibility relies on robust risk assessments and process validation, shifting responsibility onto manufacturers to ensure solvent levels remain within safe limits. The trade-off is between streamlining quality control and maintaining rigorous patient safety standards. The updated guidelines also harmonise requirements for human and veterinary medicines, promoting consistency across sectors.
Impact on stakeholders - Pharmaceutical manufacturers: Benefit from reduced testing requirements and lower operational costs, but must invest in process validation and risk assessment documentation to justify skip testing or omission. - Regulatory authorities: Face a shift from routine testing oversight to auditing manufacturers' risk assessments and process controls, requiring new expertise and resources. - Quality control laboratories: May see a decrease in routine testing workload for established processes, but could face increased demand for method validation and risk assessment support. - Patients and healthcare providers: Ultimately benefit from continued safety assurance through risk-based controls, though any reduction in testing could raise concerns if risk assessments are inadequately implemented.
Expected institutional follow-up The public consultation runs until June 2026, after which the EMA will review comments and finalise the annexes. The revised guidelines are expected to be adopted by the ICH and VICH international bodies, leading to implementation across EU member states and beyond. The EMA may also issue additional guidance on risk assessment methodologies to support consistent application.
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