EMA and HMA release joint network strategy to 2025

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The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have released a draft joint network strategy for the coming five years. A public consultation on the strategy will be open for two months.

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The European Medicines Agencies Network Strategy to 2025 was released on 6 July 2020 and outlines plans for the network for the next five years. It builds on the strategy for 2016–2020, which focused on human health, veterinary medicines, optimizing the operation of the network, and the regulatory environment.

The new strategy details how the network can enable the supply of safe and effective medicines in the face of globalisation, changes in science, medicine and digital technologies, as well as emerging health threats such as COVID-19.

It has six priority areas:

  1. the availability and accessibility of medicines
  2. data analytics, digital tools and digital transformation
  3. innovation
  4. antimicrobial resistance and other emerging health threats
  5. supply chain challenges
  6. the sustainability of the network and operational excellence.

The strategy suggests the COVID-19 pandemic will shape the future of medicines regulation nationally and at the EU level and highlights the need for pandemic preparedness.

The strategy was also informed by EMA’s Regulatory Science to 2025 strategy, which was released in March 2020 and identifies areas where advances in regulatory science are necessary.

The draft strategy is available to read in full here: https://www.ema.europa.eu/en/documents/other/european-medicines-agencies-network-strategy-2025-protecting-public-health-time-rapid-change_en.pdf

A public consultation on the strategy is open until 4 September 2020. Input can be made via a questionnaire available at: https://ec.europa.eu/eusurvey/runner/EMANStrategy2025_PublicConsultation2020

Comments received will be reviewed before production of the final draft of the document, which will be considered for adoption by HMA and EMA Management Board at the end of the year.

This follows the news that EMA and US Food and Drug Administration (FDA) have agreed new strategic priorities for medicines, including research on COVID-19 [1]. Prior to this, the two agencies signed a mutual recognition agreement to recognize each other’s good manufacturing practice (GMP) inspections [2].

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1. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA agree new priorities, including research on COVID-19 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Policies-Legislation/EMA-and-FDA-agree-new-priorities-including-research-on-COVID-19
2. GaBI Online - Generics and Biosimilars Initiative. US and EU sign milestone mutual recognition agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Policies-Legislation/US-and-EU-sign-milestone-mutual-recognition-agreement

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Source: EMA

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