Fostering regulatory collaboration to improve access to mpox medicines

Global regulators discuss available knowledge supporting mpox medicine development and approval

International regulators have published a report highlighting their considerations on the development, clinical trials and availability of vaccines and therapeutics for mpox. The report presents the outcomes of a workshop that was organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).

In August 2024, the World Health Organisation (WHO) declared mpox a public health emergency of international concern (PHEIC). The viral illness caused by the monkeypox virus is endemic in certain parts of Central and West Africa. The surge in cases in the Democratic Republic of Congo and several neighbouring countries is driven by the mpox clade I strain which has been evolving into a new sub-clade Ib similarly to what happened with the clade II mpox strain that was circulating during the 2022/2023 public health emergency. The availability of medicines has been one of the biggest challenges during these outbreaks.

Meeting participants discussed the current epidemiological status and the availability of mpox vaccines in African countries. Other topics discussed included efforts to fill the evidence gap regarding the use of vaccines in children and pregnant women, the need to establish effective surveillance systems, and the best regulatory pathways for approval of new vaccines and treatments. International regulators stressed the need for large clinical trials, which are most likely to generate the evidence required to enable faster development and rapid approval of mpox medicines. They also agreed that using a more coordinated approach would be the most effective strategy to tackle current and future public health emergencies.

About the workshop

The workshop was held virtually on 2 October 2024. It brought together representatives from international medicines regulatory authorities and experts from WHO to explore how they can support access to mpox medicines in the most affected countries during the ongoing outbreak. 

The meeting built upon the experience and knowledge gained from previous regulatory workshops held by ICMRA where international collaboration, alignment and information sharing between regulators around the world were encouraged. 

The discussion was moderated by Moji Adeyeye, Director General of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), and Marco Cavaleri, Head of Public Health Threats at EMA.