As part of the Optimising Efficiencies in Regulatory Agencies (OpERA) programme, CIRS has been working closely with six regulatory agencies in the Southern African Development Community (SADC) to evaluate their Good Review Practices, review models and approval timelines.
The comprehensive data provided by the six agencies (Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe) has enabled us to produce comparative analyses and recommend strategies for better alignment. 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 monitoring regulatory performance by publishing approval times and a summary basis of approval as well as the need for training in quality decision-making practices. 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 the Good Review Practices of countries participating in the Southern African Development Community: Alignment and Strategies for moving forward
- Evaluation of the Review Models and approval timelines of countries participating in the Southern African Development Community: 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 (firstname.lastname@example.org) if you would like to find out more about the programme.