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EMA: Global regulatory collaboration to enhance access to mpox medicinal products

25 October 2024

EMA: Global regulatory collaboration to enhance access to mpox medicinal products

International regulatory authorities recently issued a report summarizing key discussions on the development, clinical trials, and accessibility of mpox vaccines and therapeutics (document link). The workshop, organized by the European Medicines Agency (EMA) within the framework of the International Coalition of Medicines Regulatory Authorities (ICMRA), focused on strategies to enhance mpox medicinal products availability, particularly in the African regions most affected by the virus. Following the designation of mpox as a public health emergency of international concern (PHEIC), the discussion emphasized the need for large-scale clinical trials, strengthened evidence for use in vulnerable populations, and robust surveillance systems. Regulators concluded that a coordinated global approach would most effectively support rapid development and approval of treatments and vaccines to address ongoing and future public health threats.

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