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Results of Annual Regulatory Dialogue between European Commission, European Medicines Agency and US Food and Drug Administration

  • 23/06/2020
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Senior officials of the European Commission, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) held their annual regulatory dialogue on 18 June and 19 June 2020 (see, attached EMA press release of 22 June 2020). While the EMA and the FDA say to have “almost daily” interactions, the annual meetings are designed to review ongoing initiatives and define strategic priorities for the coming years.
The three agencies discussed (i) the development, review and availability of Covid-19 vaccines; (ii) possible cooperation on individualised or bespoke therapies for ultrarare diseases; (iii) the compiling of real world evidence (observational research in Covid-19 will serve as a model); (iv) orphan and pediatric medicines; and (v) the expansion of the scope of the mutual recognition agreement (MRA) of good manufacturing practice to veterinary medicines and possibly human vaccines and plasma-derived medicinal products (the first full implementation of the MRA for a range of specific human medicines was completed in July 2019 – see, Van Bael & Bellis Life Sciences News Alert of 12 July 2019).


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