EMA's challenges through 2023: Global collaboration, supply shortages, antimicrobial resistance

Regulatory NewsRegulatory News | 12 October 2021 |  By 

The European Medicines Agency (EMA) recently released its final programming document for 2021 to 2023, setting goals to address medicine availability and shortages, analysis and access to healthcare data, supply chain issues, and antimicrobial resistance.
Emer Cooke, EMA Executive Director, stated in the document’s foreword that much of the agency’s planning over the next few years will be accomplished by implementing the EMA Network Strategy and Regulatory Science Strategy, which was developed with stakeholders as a roadmap to 2025 and offers “a strategic direction helping EMA together with the Network to collectively tackle current and future challenges more effectively and seize the opportunities that new science, new technology and better data present.” (RELATED: EU regulators set network strategy to 2025, Regulatory Focus 8 December 2020)
As 2020 and 2021 were largely dominated by the impact of the COVID-19 pandemic in the European Union (EU), Cooke noted that COVID-19 will remain a challenge to EMA in the future. “EMA will pursue its effort to evaluate and supervise rapidly emerging medical innovations that give access to safe and effective treatments and vaccines against the virus,” she wrote.
EMA also described the potential impact of extending the agency’s mandate to deal with “extraordinary circumstances” in the future by building on the lessons of the COVID-19 pandemic. “The proposed Regulation will complement and further develop the core tasks already given to the Agency in its founding Regulation, notably to provide scientific advice and to assess the quality, safety and efficacy of medicinal products as part of their authorisation process,” according to the EMA document.
In terms of international collaboration, Cooke said that EMA and the European medicines regulatory network (EMRN) will continue to work with the global community on COVID-19 vaccines and treatments as well as in other areas of medicine.
“The COVID-19 pandemic has demonstrated that international collaboration is not just an opportunity but a global necessity as treatments and vaccines are common goods,” Cooke wrote. “Over the next five years EMA and the EMRN will invest even more in this transversal activity, to confirm the EU supportive, engaged and openly collaborative leadership on delivering safe, effective and high quality medicines to the EU and beyond.”
Tackling antimicrobial resistance is also a “priority area of work” for EMA, both in developing new products to address antimicrobial resistance and in ensure antibiotics available today remain effective, Cooke explained.
Supply chain challenges that lead to reduced access and availability of medical products, which have been exacerbated by the COVID-19 pandemic, is another area of focus for the agency. “EMA will work with the Member States, the Commission, the Parliament, other EU Agencies and patients and healthcare professionals to find ways to improve access and availability, which are today a daily issue across all therapeutic areas,” Cooke explained.
Integrating digital technology into regulatory processes is another goal of the agency, according to the report, with a focus on integration with external stakeholders to create “a seamless platform for the Network” within the next 5 years. A further goal is the ability to analyze large data sets and use these data sources to inform and strengthen decision-making. (RELATED: EMA goes all in on big data, Regulatory Focus 27 August 2021)
“Digital technologies, healthcare data and advanced analytics present opportunities throughout the product lifecycle, medicines development, through authorisation to post-authorisation monitoring of medicines and the conduct of independent studies,” Cooke wrote.
“Rest assured that EMA and its staff is ready to take on these new challenges and opportunities and will continue to contribute through its expertise and dedication to the benefit of public and animal health in the European Union,” she concluded.
EMA Final Programming Document 2021-2023


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