Abstract
BackgroundThis 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).MethodsA 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.ResultsParticipating 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 identified and should be considered in implementing GRelP.ConclusionsNRAs 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 fulfil 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.
Highlights
National Regulatory Authorities (NRAs) are responsible for ensuring the safety, quality, and efficacy of medicines [1], access to essential medicines is limited in many low-to-middle-income countries [2]
Information from the public domain such as documents published by South African Health Products Regulatory Authority (SAHPRA) for public comment and the Centre for Innovation in Regulatory Science (CIRS) workshops held in Singapore and South Africa were included
Strategies initiated by national regulatory authorities (NRAs) to leverage international collaboration in the form of reliance and referencing to enhance regulatory performance have been endorsed by the World Health Organization (WHO) [2]
Summary
National Regulatory Authorities (NRAs) are responsible for ensuring the safety, quality, and efficacy of medicines [1], access to essential medicines is limited in many low-to-middle-income countries [2]. The review of the quality, efficacy, and safety of medicines is considered to be one of the key functions of NRAs [4] and the timely review of applications for registration of new active substances (NASs) can significantly improve patients’ access to medicines and impact public health [1]. The implementation of good review practices (GRevP) supports improved regulatory performance and contributes to the advancement of convergence of NRA regulatory requirements [5, 6].This coupled with the alignment of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) technical guidelines would create opportunities for reliance based on the regulatory decisions of other NRAs and supports possibilities for work sharing and joint regulatory initiatives [7].
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