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 [...]

2021-07-19T14:47:04+00:00September 8th, 2020|Tags: , |

CIRS RD Briefing 74 – OpERA programme

CIRS has collected regulatory assessment data for over 20 years, initially with ICH and ICH-observing countries. The OpERA programme, “Optimising Efficiencies in Regulatory Agencies (OpERA)”, was initiated through CIRS [...]

2021-06-07T10:56:57+00:00January 8th, 2020|Tags: , |

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 [...]

2021-01-18T17:15:51+00:00December 12th, 2019|Tags: , , |

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 [...]

2021-01-18T17:08:49+00:00March 14th, 2019|Tags: , , |