EMA: Report on First Bilateral Meeting with APIC Published
The EMA has published the highlights of its first bilateral meeting with the Active Pharmaceutical Ingredients Committee (APIC). Topics included GMP oversight of API manufacturers, the reuse of recovered solvents and nitrosamine risks.
On inspection reliance, APIC raised perceived differences in the oversight of EU and non-EU API manufacturers. The EMA pointed to complementary controls for imported active substances, including the responsibilities of manufacturers and Qualified Persons, risk-based inspections and international information sharing.
Solvent recovery: The EMA recommends reusing recovered materials within the same manufacturing process and avoiding their use in the final manufacturing steps. Alternative approaches may be accepted on a case-by-case basis if supported by a robust risk assessment and appropriate scientific justification.
Authorities may request additional data or confirmatory testing where a nitrosamine risk assessment is insufficiently supported. The parties also discussed the planned certification of Active Substance Master Files (ASMF); implementation details are still pending.
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