EU regulators set network strategy to 2025

Regulatory NewsRegulatory News | 08 December 2020 |  By 

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have adopted their next five-year network strategy following its adoption by the EMA’s management board and HMA.
The 53-page strategy, which was released for consultation in July, focuses on six priority areas for the network of regulators:
  • availability and accessibility of medicines;
  • data analytics, digital tools and digital transformation;
  • innovation;
  • antimicrobial resistance and other emerging health threats;
  • supply chain challenges; and
  • the sustainability of the network and operational excellence.
In its overview of responses to the consultation, EMA says that three-quarters of respondents were satisfied with the overall strategy, with only a handful of respondents expressing dissatisfaction with the network’s direction. The agency also notes that the strategy is aligned with the European Commission’s recently adopted pharmaceutical strategy. (EC’s new pharmaceutical strategy highlights support for innovation, R&D, Regulatory Focus 25 November 2020).
While the six priority areas were selected last year before the emergence of COVID-19, the strategy itself reflects lessons learned from the pandemic. The document itself is meant to provide a high-level overview of the network’s strategy over the next five years, with more specific details to follow in work plans developed by EMA and HMA in the coming years.
“The COVID-19 pandemic has highlighted the pivotal role of medicines regulation for the protection of public health,” said EMA Executive Director Emer Cooke, who began her term heading up the agency last month. “Lack of availability of medicines, either because they are not marketed or due to supply disruptions, has shown to pose serious threats to patient and animal health, animal disease control programs and sustainable livestock production. This strategy ensures that we join forces across the EU to effect tangible improvements for citizens.” (RELATED: Rasi signs off as EMA chief, Cooke to take the reins amid pandemic, Regulatory Focus 13 November 2020).
For each of the six priority areas, the strategy highlights a set of strategic goals and recommendations to help achieve those goals.
For example, to increase the availability and accessibility of medicines in the EU, the strategy calls for the development of “efficient and targeted regulatory measures” and a slew of other actions, including the removal of national barriers and increased coordination among the European Medicines Regulatory Network. Other goals include optimizing “the path from development, evaluation through to access for medicines through collaboration between medicines regulators and other decision makers.”
Among the lessons drawn from COVID-19 are an acknowledgement of the potential to use real-world data to evaluate health policy decisions and supply chain vulnerabilities caused by “longer supply chains” and spikes in demand for repurposed medicines.
EMA, European medicines agencies network strategy to 2025


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