Work sharing

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: [...]

2024-02-12T12:09:04+00:00December 12th, 2023|Tags: , , |

CIRS RD Briefing 89 – Review of HTA outcomes and timelines in Australia, Canada, Europe and the UK 2018-2022

This R&D Briefing presents data from HTADock, an ongoing metrics study that collects publicly available data on new active substances (NASs) appraised by key international HTA agencies, each with [...]

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 [...]

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the pharma industry

Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current [...]

Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries

Background: The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and [...]

CIRS RD Briefing 86 – Review of HTA outcomes and timelines in Australia, Canada and Europe 2017-2021

The Briefing presents data from HTADock, an ongoing metrics study that collects data on new active substances (NASs) appraised by eight HTA agencies and analyses synchronisation between the regulatory [...]

2024-02-13T16:02:47+00:00October 26th, 2022|Tags: , , |

Regulatory work-sharing initiative in Africa: ZaZiBoNa, past, present and future

PREFACE: The role of regulatory authorities in the health system is to ensure the quality, safety and efficacy of medical products. It is acknowledged that regulatory authorities are at [...]

2022-09-21T17:02:58+00:00September 21st, 2022|Tags: , , |
Go to Top