EMA calls for regulatory collaboration to improve access to mpox

The European Medicines Agency (EMA) is calling for greater regulatory collaboration to improve access to mpox. International experts discussed the current knowledge supporting the development and approval of these drugs. In addition, for solve the problem of vaccine availability and improve access to treatments for this pathology in vulnerable countries. They also published a report outlining their considerations for development and clinical trials. This paper presents the results of a workshop organized by the EMA under the auspices of the International Coalition of Medicines Regulatory Authorities (ICMRA).

In August this year, the World Health Organization (WHO) declared mpox a public health emergency of international concern (PHEIC). The disease, caused by monkeypox virus, is endemic in parts of central and western Africa, the EMA statement explained. The increase in incidence in the Democratic Republic of the Congo and several neighboring countries is due to the mpox strain of clade I. This has evolved into a new subclade Ib. This situation is similar to what happened with the mpox clade II strain circulating in 2022 and 2023. Availability of medications has been one of the biggest challenges during these outbreaks.how they influenced.

Workshop on supporting access to medicines

Thus, the meeting participants analyzed the current epidemiological situation and the availability of smallpox vaccines in these African countries. Similarly, other topics discussed included attempts to fill the evidence gap regarding vaccine use in children and pregnant women. Also the need to establish effective supervisory systems and better regulatory measures. International regulatory authorities have emphasized the need for large-scale clinical trials. This will likely generate the evidence needed for faster development and faster approval of mpox drugs. They also agreed that taking a more coordinated approach would be the most effective strategy to address current and future public health emergencies.

The International Coalition of Medicines Regulatory Authorities (ICMRA) virtual workshop on mpox took place on October 2nd. During the meeting, representatives of international drug regulatory authorities and WHO experts discussed how they can support access to mpox in the most affected countries during the ongoing outbreak. This is due, among other things, to inequalities in access to treatments and vaccines, especially in low-income countries in Africa where access to health interventions is critical.

The Importance of Research

They also addressed the need to address the lack of research into treatments for the most affected populations and the importance of conducting large clinical trials. Experts also discussed the approval of the MVA-BN vaccine in children and its use in various contexts. Moreover, they emphasized the importance of a coordinated and collaborative approach improve access to medicines in these vulnerable countries.

Finally, they proposed dosing strategies to optimize vaccine availability. They therefore emphasized the importance of obtaining results from clinical trials of antiviral drugs such as tecovirimat. ICMRA agreed that it was important avoid fragmentation of clinical trials and promote international collaborationas they explained. This discussion was moderated by the Director General of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC), Moji Adeyeye, and the Head of Public Health Threats at the EMA, Marco Cavaleri.

You may also be interested…