Roadmap for Regulatory Performance
Every regulatory authority in the world has an ambition to improve its performance. In order to achieve this, agencies often establish performance indicators which they use for measuring and [...]
An independent perspective on the East African Community Medicines Regulatory Harmonisation initiative
African regulators are taking bold transformative steps to optimise the effective and efficient use of their agency resources to assure access to quality, safe and effective medicines. In particular, [...]
Keyter et al 2020 – Can standardisation of the Public Assessment Report improve benefit-risk communication?
Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as [...]
Sithole et al 2020 – Evaluating the success of ZaZiBoNa
The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa [...]
Keyter et al 2020 – Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa
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 [...]
Keyter et al 2019 – Evaluation of the performance of the South African regulatory agency
Background: Timely access to new medicines may be addressed through strengthening of registration efciencies and timelines by establishing and refning value-added registration processes, resources, and systems. The aims of [...]
Keyter et al 2019 – South African Medicines Control Council: Comparison of Its Registration Process
Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move [...]
CIRS RD Briefing 50 – Cross-regional comparison of regulatory environment in emerging markets
The emerging markets of Asia-Pacific, the Middle East, Africa and Latin America are becoming increasingly important to pharmaceutical companies in their global strategies for the registration of new medicines [...]
CIRS RD Briefing 48 – Assessing the regulatory environment – Middle East and Africa
The regulatory agencies in the Middle East and African region that were included in this study share a common goal with the research-based pharmaceutical companies that they regulate. This [...]