The US Food and Drug Administration (FDA) announced their inclusion in the alliance this week, which enables drug and active pharmaceutical ingredient (API) manufacturing plant inspections to be mutually recognised in their respective territories.
The Mutual Recognition Agreement – signed between the European Medicines Agency (EMA) and the US FDA in March last year – already recognises good manufacturing practice (GMP) inspections carried out in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and UK.
Mutual benefits for regulators include being able to rely on each other’s inspections to avoid duplication, and making better use of inspection resources to focus on higher risk sites, said the EMA.
Industry group Medicines for Europe agreed the inclusion for four additional EU Member States will benefit regulatory authorities.
“For regulators, this will enable them to focus limited inspectorate resources on higher risk inspections and work which is in the best of interest of patient protection,” director general Adrian van den Hoven told us.
It is a great opportunity to boost economic and regulatory cooperation between the EU and the US, he added.
And for industry?
Eastern Europe has a large pharmaceutical manufacturing base, especially for generic and biosimilar medicine production, said van den Hoven, who argued the decision is “very important for our industry for the future.”
While this decision will not directly improve market access for Eastern European countries – as the companies exporting to the US already have US FDA GMP approval – over time, it will reduce the number of duplicate inspections, we were told.
As a result, time and resources of both companies and inspectors will be saved, he added.
“This is an important step forward to ensure the mutual recognition agreement on good manufacturing practice will cover the whole EU & US territories.”