Major milestone reached in EU-US mutual recognition on pharmaceuticals


  • Priscilla Lynch
  • Univadis Medical News
El acceso al contenido completo es sólo para profesionales sanitarios registrados. El acceso al contenido completo es sólo para profesionales sanitarios registrados.

A major milestone on mutual recognition of pharmaceutical oversight between the European Union (EU) and the United States (US) has been reached.

The recognition this month by the US Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State to be assessed positively by the FDA, marks the full implementation of the EU-US Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for human medicines in their respective territories. This can make it faster and less costly for both sides to bring medicines to the market and frees up resources to inspect facilities in other large producing countries.

The EU and US have comparable procedures to carry out good manufacturing practice inspections for human medicines and together account for more than 80 per cent of global sales of new medicines.

From now on, a batch testing waiver will also start to apply. This means qualified persons in EU pharmaceutical companies will be relieved of their task of carrying out quality controls that have already been carried out in the US.

The MRA implementation work will continue with a view to expanding the operational scope to veterinary medicines, human vaccines and plasma-derived medicinal products.