Regulatory approaches: expert meeting in Geneva
Regulators from many different African countries took part in a recent Pediatric Praziquantel Consortium meeting, held in Geneva in October. An intensive two-day agenda encompassed discussions of the entire regulatory approach for the Consortium’s new praziquantel pediatric formulation.
Topics discussed included ethical considerations, proposed regulatory approaches for Sub-Saharan Africa, the encouraging progress being made on regulatory harmonization in Africa and the role of the African Vaccine Regulation Forum (AVAREF) in facilitating vaccine registration. There were many discussions and presentations on how to best accelerate submission and review. Potential avenues that were highlighted in addition to already existing approaches were for example the harmonized dossier, joint assessment and joint inspection to fast track accessibility in an entire economic block, like the East African Community.
It was clear that many of the regulators were already aware of the threat from pediatric schistosomiasis, but post-meeting feedback included comments that participants had acquired a more detailed understanding of the issue, and a better appreciation of the numbers of untreated children involved. All taking part felt that the exercise had been very worthwhile, allowing shared insights into the remaining challenges and the work in progress to develop and register a new praziquantel pediatric formulation for preschool-aged children suffering from schistosomiasis.