Background This study sought to identify criteria and current practices for implementing an abridged review process and
understanding barriers and enablers in utilizing reliance models and to offer recommendations for the implementation of an
abridged review process in South Africa based on good reliance practices (GRelP).
Methods A questionnaire was completed by six national regulatory authorities (NRAs) to determine criteria and current
practices for implementing an abridged review process. In addition, two focus group discussions were conducted on the
practical implementation of an abridged review process based on GRelP.
Results Participating NRAs indicated that reliance would be placed on one reference agency. Applications submitted to
NRAs for an abridged review had to be identical to those submitted to the reference agency. Unredacted reference agency
assessment reports would be required to facilitate the abridged review process. A full technical dossier would also be required,
but only parts would be assessed during the abridged review. Focus groups indicated that abridged review elements had been
identifed and should be considered in implementing GRelP.
Conclusions NRAs strive to improve regulatory performance and accelerate approval times; however, many continue to face
challenges due to resource constraints. Increasing workloads, advancing technologies, and limited expertise require NRAs
to leverage regulatory convergence initiatives, collaborative registration procedures, and functional regional, continental
and international networks to fulfl regulatory mandates. Recommendations for the implementation of an abridged review
process and a framework for GRelP have been made with a view to optimise regulatory review processes in South Africa.”
Keyter, A., Salek, S., McAuslane, N. et al. Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa. Ther Innov Regul Sci 54, 1199–1207 (2020). https://doi.org/10.1007/s43441-020-00144-0
