EMA – Publication of the 1-year report on the Early dialogue with healthcare professional organisations for marketing authorisation applications

Building on the positive experience gained from the pilot for early dialogue with patient organisations for orphan Marketing Authorisation Applications that ran from January 2021 to May 2022, the EMA proposed to replicate and extend the methodology to non-orphan medicinal products as well as healthcare professional (HCP) organisations.

The EMA released its 1-year report on this new early dialogue with healthcare professional organizations concerning marketing authorisation applications (MAAs). This initiative aims to strengthen collaboration between healthcare professionals and regulatory bodies to ensure more effective and patient-centred drug evaluations. By involving professionals early in the marketing authorisation process, the EMA seeks to address critical clinical concerns, improve the quality of evidence, and enhance public health outcomes. The report highlights key findings, challenges, and recommendations from the first year of this collaborative effort.

Find more information on the EMA’s work with Healthcare professionals as well key documents on this work on the EMA Website.

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