Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority

During the DIA Global Annual Meeting 2023, Lorraine Danks, Boitumelo Semete-Makokotlela, Sam Salek and Stuart Walker developed and presented a poster in which they shared the results, recommendations and [...]

2023-08-15T23:22:57+00:00August 15th, 2023|Tags: , , , |

CIRS RD Briefing 88 – New drug approvals in six major authorities 2013-2022: Focus on orphan designation and facilitated regulatory pathways

This R&D Briefing presents the results from the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the [...]

2023-07-04T18:27:55+00:00July 3rd, 2023|Tags: , , |

CIRS RD Briefing 70 – New approvals in six regulatory authorities 2009-18

Major improvements in the regulatory environment as well as changes in strategies of multinational companies have led to a general decrease in the time to marketing authorisation and improved consistency [...]

2021-01-19T11:08:18+00:00May 13th, 2019|Tags: , |

Globally Applicable Facilitated Regulatory Pathways to Improve Equitable Access to Medicines

A variety of approaches have been developed to accelerate the regulatory review of medicines. We characterise these various expedited pathways as facilitated regulatory pathways (FRPs): regulatory pathways designed to accelerate [...]

2023-09-20T09:00:05+00:00July 19th, 2017|Tags: , |