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 monitoring both their efficiency and effectiveness. This book is the outcome of a three-year research program led by Dr Andrea Keyter, which has resulted in a roadmap for regulatory performance.
Dr Murray Lumpkin, Lead for Global Regulatory Systems Initiatives with the Bill and Melinda Gates Foundation kindly wrote the foreword to the book. In this he stated that:
“The authors have successfully linked the studies and outcomes, described in this book, with the WHO Global Benchmarking Tool (GBT) indicators and have helped demonstrate what South African Health Products Regulatory Authority (SAHPRA) must do to fulfil its vision of become a leading WHO recognised medicines regulatory authority… I believe the South African’s experience could provide an approach for other agencies looking to establish a quality medicines regulatory agency as an integral part of their own national quality health care system.”
We hope that this book will be a valuable resource for regulatory agencies (particularly in emerging markets) and companies alike, and will serve as a blue print, providing practical solutions to support initiatives for regulatory reform.
Keyter AA, Salek S, Walker SR. Roadmap for regulatory performance: South Africa’s experience in enhancing the pharmaceutical review process. Amsterdam: Off Page; 2020.