EMA and EU medicines regulatory joint five-year strategy

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The Europeans Medicines Agency (EMA) and the European Union’s (EU) Heads of Medicines Agencies (HMA) have published their joint strategy to 2025: Protecting public health in a time of rapid change [1].

Review committee architect V15a16

The Europeans Medicines Agency (EMA) and the European Union’s (EU) Heads of Medicines Agencies (HMA) have published their joint strategy to 2025: Protecting public health in a time of rapid change [1].

The strategy outlines how the European medicines regulatory network can work on ensuring that safe and effective medicines that meet patients’ requirements have a continued supply. This considers emerging health treats, such as the COVID-19 pandemic, as well as challenges posed by developments in science, medicine, digital technologies and globalization. It highlights that this is a time of rapid change, and the COVID-19 pandemic has shed light on current shortcomings in medicines regulation.

The European medicines agencies network strategy to 2025 highlights six key areas that should be focused on over the next five years:

  • availability and accessibility of medicines
  • data analytics, digital tools and digital transformation
  • innovation
  • antimicrobial resistance and other emerging health threats
  • supply chain challenges
  • network sustainability and operational excellence.

Within these areas, strategic goals have been identified which will become concrete actions in the coming five years. In forming the strategy, the COVID-19 pandemic highlighted the threats posed by lack of availability of medicines and a need for suitable medicines regulation that protects public health now and in the future.

This strategy follows the announcement of the adoption of the latest Pharmaceutical strategy for Europe which strongly promotes generics and biosimilars production and uptake in the EU [2]. This has also been strongly influenced by the COVID-19 pandemic and the desire to ensure uninterrupted access to all medicines, at all times.

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To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. European Medicines Agency. Heads of Medicines Agency. European medicines agencies network strategy to 2025 [homepage on the Internet]. [cited 2021 Jan 29]. Available from: https://www.ema.europa.eu/en/documents/report/european-union-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf
2. GaBI Online - Generics and Biosimilars Initiative. A European pharmaceutical strategy promoting generic and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 29]. Available from: www.gabionline.net/Generics/General/A-European-pharmaceutical-strategy-promoting-generics-and-biosimilars 

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