Facilitated regulatory pathways

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 [...]

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: , |
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