The mutual recognition agreement between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) sees good manufacturing practice (GMP) inspections performed by European countries deemed comparable to those undertaken by the latter agency.
The total number of accredited European countries now stands at 20, with plans for all European Union (EU) member states to be added to the agreement by July 2019.
As part of the statement, the EMA outlined the benefits of the transatlantic agreement:
- The ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured
- Prioritising inspections of medicines manufacturing sites for higher risk cases
- Reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured
- Improving the 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
The move for greater global regulatory harmonisation has also seen the EU foster stronger ties with Japan.
In July, an existing mutual recognition agreement between the regions was expanded to cover APIs, sterile medicines and biologic medicines. As a result, inspection of the products is no longer needed on their arrival in either the EU or Japan.