Abstract

Certificates of Suitability (CEPs), issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM), are widely used to support the registration and lifecycle management of active pharmaceutical ingredients (APIs) by demonstrating compliance with European Pharmacopoeia (Ph.Eur.) monographs. Within the EU, regulatory frameworks permit certain CEP variations (classified as notifications, minor variations or major variations) to be implemented prior to formal approval, depending on risk and procedural category. By contrast, Australian regulatory requirements under Section 9D of the Therapeutic Goods Act 1989 mandate prior approval by the Therapeutic Goods Administration (TGA) for almost all changes to registered medicines, including API‑related variations supported by amended CEPs.

This article examines the regulatory misalignment between EU and Australian implementation frameworks for CEP‑supported API changes and highlights the operational, governance and supply‑chain risks that arise for the industry when approval timelines are not aligned across jurisdictions.