EMA: No further Extension of GDP Certificates in 2025

On 24 February 2025, the European Medicines Agency (EMA) published an update in the section "Regulatory expectations and certificates following the end of the COVID-19 public health emergency."

Background

During the COVID-19 pandemic, various exemptions were introduced for GDP inspections as well as for the validity and extension of GDP certificates. The aim was to ensure the supply of medicines despite the restrictions caused by the pandemic.

In December 2023, the GMP/GDP Inspectors Working Group (IWG) announced that the validity of GDP and GMP certificates that expired at the end of 2023 would be extended until 2024 or until the next on-site inspection, whichever occurred first.

No Further General Extension

In its latest announcement, the EMA clarifies that a general extension of GDP certificates will no longer be granted in 2025.

The following justification is given: "The working group took into account that national competent authorities (NCAs) had resumed regular on-site inspections. It also considered that NCAs are using other methods to gather compliance information, such as distant assessments and inspections that international partners carry out. These methods enabled decisions on certificate validity. They also helped reduce inspection backlogs, which are expected to be resolved in 2025."

However, in individual cases, the national authorities may decide on a case-by-case basis whether any additional extension to a GDP certificate is needed.

Questions regarding GDP certificates and their validity should be directed to the competent authority that issued the respective certificate.