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 [...]

2020-11-19T13:40:55+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: , , |