The European medicines regulatory network is on track to meet its strategic goals and objectives covering availability and accessibility of medicines; data analytics, digital tools, and digital transformation; innovation; antimicrobial resistance and other emerging health threats; supply-chain challenges; sustainability of the network and operational excellence, according to the midterm report of the network strategy.
“Despite the unprecedented challenges presented by the COVID-19 pandemic and the resource that has been deployed across the medicines regulatory network in response, a lot of progress has been made in the six priority focus areas of our network strategy,” says Emer Cooke, EMA’s Executive Director. “The end of the public health emergency and the lifting of the business continuity planning means we will once again be in a position to focus more fully on delivering patient-relevant medicines and digital transformation while continuing to deal with health threats and supply issues.”
The network strategy was published in December 2020 by EMA and the Heads of Medicines Agencies (HMA). As the main strategy guiding the delivery of the operational, regulatory, and scientific output of the EU medicines regulatory system, the EMANS identified shared challenges, goals, and priorities for a five-year period, to give strategic direction to the work of the European medicines regulatory network.
Karl Broich, Chair of the HMA Management Group, said: “The European medicines regulatory network, with its unique way of collaborating and pooling scientific and regulatory expertise across Europe, has just emerged from three long years of the COVID-19 health emergency. Difficult periods often serve to stress test systems and reveal facture lines and valuable learnings. From the network’s point of view, this experience has strengthened the desire to continue building together a better regulatory system and all the priorities envisioned as part of the EMANS.”
The midterm report offers a snapshot of achievements from January 2021 to June 2023. It revisits the original goals and objectives as well as the actions proposed to deliver them. According to the report, the original proposal remains valid and relevant. EMA and HMA will continue to deliver successfully on the remaining actions.
The EMANS sets out how the network continues to enable the supply of safe and effective medicines, adapting to new developments in science, medicine, digital technologies, globalisation and emerging health threats, such as antimicrobial resistance (AMR) and the COVID-19 pandemic. It was built following an extensive period of outreach, analysis, and consultation with EMA’s scientific committees, stakeholders, and EU regulatory partners through a public consultation before its final publication in December 2020.
The strategy outlined six priority focus areas in line with the European Commission's roadmap for a Pharmaceutical strategy for Europe. Initial work on the pandemic was fed into the strategy's development and the numerous lessons learned from COVID-19 will continue to inform future reviews of the strategy and subsequent work plans. The EMANS identifies strategic goals and objectives for each focus areas, which were subsequently translated by EMA and the HMA into concrete actions in their respective detailed work plans and programmes. Implementation of the EMANS also took place through the Regulatory Science Strategy (RSS) to 2025. Mid-point reporting of the RSS includes key achievements to March 2023 (which are also reflected here) and we have elaborated on further achievements since.
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