Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2024 Jun 5:11:1399947.
doi: 10.3389/fmed.2024.1399947. eCollection 2024.

A decade of collaboration in medicines regulation: healthcare professionals engaging with the European Medicines Agency

Ivana Silva  1 , Giulia Gabrielli  1 , Juan Garcia Burgos  1 , Isabelle Moulon  1 , Gonzalo Calvo Rojas  2 , Ulrich Jaeger  3   4 , Rosa Giuliani  5
Affiliations
Review

A decade of collaboration in medicines regulation: healthcare professionals engaging with the European Medicines Agency

Ivana Silva et al. Front Med (Lausanne). .

Abstract

The article shows that the input given by healthcare professionals (HCPs) adds value to the regulatory processes surrounding the development, authorisation, and monitoring of a medicine, but is also an instrument for accountability, trust, mutual exchange as well as an insight into the public health issues that matter most to one of the key stakeholder groups the Agency works with. We highlight the role of HCPs in the EU regulatory process and take stock of the first 10 years of the Framework for Interaction with HCPs to describe how practises have evolved over this time to meet the goals of informing, consulting and improving trust in the EU regulatory system. We will analyse what led European Medicines Agency (EMA) to develop this framework through to the next steps and where the interaction might lead in the future.

Keywords: European Medicines Agency; healthcare professionals (HCPs); public Health; regulation of medicines; stakeholder engagement.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Frameworks for engagement.
Figure 2
Figure 2
Journey of engagement with HCPs.
See this image and copyright information in PMC

References

    1. The European Parliament and the Council of the European Union (2004). Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, article 78. Official Journal of the European Union. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A32004R0726 (Accessed March 7, 2024).
    1. European Medicines Agency (2016). European Medicines Agency stakeholder relations management framework. Available at: https://www.ema.europa.eu/en/documents/other/european-medicines-agency-e... (Accessed March 7, 2024).
    1. European Medicines Agency (2011). Framework for interaction between the European Medicines Agency and healthcare professionals. Available at: https://www.ema.europa.eu/en/documents/other/framework-interaction-betwe... (Accessed March 8, 2024).
    1. European Medicines Agency (2024). European experts. Available at: https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-reg... (Accessed March 8, 2024).
    1. European Medicines Agency (2013). Mandate, objectives and composition of the Healthcare Professionals Working Party. Available at: https://www.ema.europa.eu/en/documents/other/mandate-objectives-composit... (Accessed March 8, 2024).