Published by EMA News 31/05/2023

Today, the European Union (EU) and the United States (US) have made important progress towards enabling mutual recognition of inspections of manufacturing facilities of certain veterinary products. The Food and Drug Administration (FDA) has recognised the capability of 16 EU Member States to carry out good manufacturing practice (GMP) inspections for certain veterinary products at a level equivalent to the US. At the same time, the EU also recognised the FDA as an equivalent authority for GMP inspections of sites manufacturing veterinary medicines.

This follows the extension of the scope of the mutual recognition agreement (MRA) between the EU and the US to veterinary products on 11 May 2023.

The Member States whose GMP inspections for veterinary medicines are recognised by the FDA are Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Luxembourg, Netherlands, Poland, Portugal, Slovenia and Spain.

Teams from the European Commission (EC), EU national competent authorities (NCAs), EMA and the FDA continue working closely to ensure the timely assessment of the remaining 11 competent authorities of Member States now that the difficulties brought about by the COVID-19 pandemic have been largely removed.

The MRA allows regulatory authorities in the EU and the US to rely on the results of inspections of manufacturing sites for veterinary products conducted in the respective territories of the parties. The aim is to strengthen reliance on the inspection expertise and resources between EU and US regulators. From now on, the FDA should rely on inspections conducted by these 16 Member States also for veterinary products and EU Member States and EMA will rely on inspections conducted by the FDA.

Benefits of the MRA for EU authorities and the FDA include:

  • the ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured;
  • prioritising inspections of medicine manufacturing sites for higher-risk cases;
  • reassuring users that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured;
  • improving the regulators’ ability to identify and address potential problems at manufacturing sites before they become a public health risk;
  • reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.
  • reliance on inspections conducted by the MRA partner waives the need for inspections during assessment of a marketing authorisation application or variation and hence contributes to faster access to medicines.

The implementation of the EU-US MRA is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human and veterinary medicines.

This recognition of inspections of facilities manufacturing veterinary products builds on the successful implementation of the MRA for human medicines. Already since 1 November 2017, EU Member States and EMA have been able to rely on FDA’s inspection results for certain categories of medicinal products for human use.

In December 2019, the FDA and the EC agreed in principle to work towards extending the scope of the EU-US MRA to veterinary products. Teams from the EC, EU NCAs, EMA and the FDA have been auditing and assessing the respective supervisory systems for veterinary products since 2018. The schedule for these assessments has been agreed between the EU and the US.

In the EU, MRAs are trade agreements that aim to facilitate market access and encourage greater international harmonisation of compliance standards while protecting consumer safety. The EC is responsible for negotiating MRAs with partner countries on behalf of the EU. Inspections of manufacturing sites are carried out by NCAs of EU Member States. EMA plays an important role in coordinating these activities in collaboration with the Member States.