EMA Updates Procedure for Coordinating GMP Inspections
EMA has updated its procedure for coordinating GMP inspections for centrally authorised medicinal products. Version 3 has applied since 10 September 2026 and replaces Version 2.
The document forms part of the Compilation of Union Procedures on Inspections and Exchange of Information (CoUP), which comprises the EU procedures and templates for GMP and GDP inspections.
Previously, each inspection requested by EMA was generally expected to involve both a Leading Authority and a Supporting Authority. A single authority could conduct an inspection only in certain exceptional circumstances.
The new version introduces greater flexibility: a Supporting Authority is no longer required in every case. Where it is considered unnecessary – for example, for certain quality control laboratories, very small manufacturing sites or sites with only one Supervisory Authority – a single authority may perform both roles.
At the same time, EMA intends to continue promoting joint inspections where appropriate. The revised procedure also clarifies the selection of the Leading Authority and the planning of routine and pre-approval inspections. It does not introduce new direct GMP requirements for companies.
Source:
EMA: Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be interested in the following articles:
