Assessing the use of risk-based approaches in four major agencies

Introduction Over the last years, several regulatory agencies have developed risk-based approaches for the regulatory assessment of marketing authorisations of New Active Substances (NASs) as strategies to efficiently use [...]

2024-07-09T15:21:30+00:00July 9th, 2024|Tags: , , |

CIRS RD Briefing 94 – Value of Reference Agency Reports in Enabling Reliance

Access to information, including the assessment documents of reference national regulatory agencies (NRA), is a key enabler of regulatory risk-based decision making. It promotes an understanding of what was [...]

2024-06-20T09:33:23+00:00June 20th, 2024|Tags: , , |

CIRS RD Briefing 92 – Appraising the usability of public assessment reports for reliance

Regulatory reliance facilitates regulatory approvals, allows the use of resources more efficiently, and ultimately serves patients by accelerating access to quality-assured, safe, and effective medicines. The World Health Organisation [...]

2024-05-31T08:07:57+00:00May 29th, 2024|Tags: , , |

CIRS RD Briefing 91 – Approaches to Implementing Regulatory Reliance: Considerations for Agencies

This CIRS briefing delves into the increasingly pivotal role of regulatory reliance in the global pharmaceutical landscape. Reliance is defined by World Health Organization (WHO) as the act whereby [...]

HTA Timelines and Outcomes for MHRA-Approved NASs via Reliance/Work-sharing Routes

During ISPOR Europe 2023 in Copenhagen, Belen Sola presented a poster entitled ‘Study of HTA Timelines and Outcomes for MHRA-Approved NASs in the Post-Brexit UK via Reliance/Work-sharing Routes'. Background: [...]

2024-07-09T08:26:09+00:00December 12th, 2023|Tags: , , |

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: , , , |
Go to Top