DIA Europe 2024

This session will offer a platform for dialogue on the operationalization of AMA and will discuss proposals on improved collaboration in Africa on regulatory harmonisation and convergence, application of reliance pathways and digitalisation. As efforts on the African continent are concentrated on accelerating the operationalization of the African Medicines Agency (AMA), it is important to consider and leverage the experience and learnings from mature regulatory agencies such as EMA and international work-sharing schemes like WHO CRP, EUM4All, Swissmedic MAGHP and ACCESS Consortium. As a new, modern regulatory agency, AMA has the potential to establish a robust and unique regulatory framework to address gaps and inconsistencies in the national regulatory systems in the regions as well as optimize technical capabilities, regulatory expertise,? and digital tools to drive efficient and sustainable regulatory operations at the continental level. Great strides have been made in enhancing regulatory harmonization and convergence in Africa via the Africa Medicines Regulatory Harmonization initiative and its partnership platform and the Regional Economic Communities' (RECs) implementation of several joint assessment procedures (JAPs) (e.g., EAC, ZAZIBONA and ECOWAS).? The need to strengthen harmonisation of other parts of the registration is also imperative. To further enhance collaboration and work-sharing, it is imperative that AMA considers lessons learnt from the various regional JAPs and international regulatory work-sharing procedures. Given the positive impact of digitalization, it is vital that AMA implements digital tools, to drive efficiencies in its operations and provides the utmost benefits to all stakeholders in the regulatory ecosystem, especially patients.? This session will highlight regional and international experiences from joint assessment procedures, and how these can uplift the Africa regulatory ecosystem including advancing maturity of several national regulatory agencies and RECs in Africa. The session will also cover the adoption of digitization initiatives on the continent and offer a platform for engagement and dialogue on optimizing the AMA operationalization.?