Milestone – 20 years of regulatory collaboration EMA and FDA

This month, 20 years ago, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) started their regulatory collaboration in which they exchange information about certain topics between experts on a regular basis. This confidential exchange of information covers the whole lifecycle of medicinal products.

The aim of this collaboration is to better align and improve scientific and regulatory quality. Over the years, several clusters have been created to cover many therapeutic areas or types of medicinal products, like oncology, biosimilars and orphan medicinal products. Other examples of this collaboration are the mutual recognition agreement, signed in 2017, in which it was agreed to share full GMP inspection reports between the agencies, and the parallel scientific advice, in which it is possible to receive simultaneous scientific advice from EMA and FDA on scientific issues during the development of medicinal products. 

The long-term collaboration between EMA and FDA has facilitated exchange of critical information and deepened the understanding of scientific and regulatory decisions. Together this will optimize the development of medicinal products, avoid unnecessary duplication and allows patients timely access to medicinal products. 

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