As part of the Optimising Efficiencies in Regulatory Agencies (OpERA) programme, CIRS has been working closely with regulatory agencies in the East African Community Medicines Regulatory Harmonisation (EAC-MRH) initiative to evaluate their Good Review Practices, review models and approval timelines.
The comprehensive data provided by the seven agencies (Burundi, Kenya, Rwanda, South Sudan, Tanzania, Uganda and Zanzibar) has enabled us to produce comparative analyses and recommend strategies for better alignment as the African Medicines Agency is operationalised. These have recently been published in a two-part series in the Regulatory Science section of Frontiers in Medicine. The recommendations from the first paper include investment in staff training and education, improving communication with applicants and publishing a summary basis of approval. The second paper underlined the importance of establishing a method for documenting all the key milestones as well as target times.
The two papers can be downloaded via the links below:
- Evaluation of good review practices in member authorities of the East African Medicines Regulatory Harmonisation initiative: strategies for alignment with African Medicines Agency
- Evaluation of the review models and approval timelines of authorities participating in the East African Medicine Regulatory Harmonisation initiative: alignment and strategies for moving forward
We hope that the OpERA approach taken in this study could provide a model for other regulatory agencies, particularly in emerging economies. The OpERA programme is open to all regulatory agencies, regardless of size or maturity; please don’t hesitate to get in touch with Professor Stuart Walker (swalker@cirsci.org) if you would like to find out more about the programme.