Progress has been made between the EU and US, to bring about a mutual recognition agreement (MRA) for manufacturing facility inspections of veterinary products.
The FDA has recognised 16 EU Member States (MS) capability to carry out inspections for good manufacturing practice (GMP) for certain veterinary products. At the same time, the EU has also recognised the FDA as an equivalent authority for GMP inspections of sites manufacturing veterinary medicines.
This development follows the recent expansion of the EU-US MRA on 31 May to include veterinary medicines. The previous iteration of the MRA – in force since November 2017 – only covered certain pharmaceuticals intended for human use.
The FDA now recognises GMP inspections for veterinary medicines in: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Luxembourg, Netherlands, Poland, Portugal, Slovenia and Spain.
The MRA aims to strengthen reliance on inspection expertise and resources between EU and US regulators.
Under these updated terms, the FDA will now rely on inspections for veterinary products conducted by the recognised 16 MS, and the EU MS and the EMA will rely on inspections conducted by the FDA.
The US drug regulator is expected to conclude its assessment of the capability of all national competent authorities responsible for veterinary products in EU MS by mid-2024, according to the EMA.
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