Webinar on Public Assessment Reports (PARs)
If you missed it, you can watch the full webinar here, available in Spanish, English and Portuguese. Join us for a webinar on public assessment reports (PARs) on [...]
Evaluation of Zambian Medicines Regulatory Authority review process – Chisha 2024
Purpose: This study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones and target timelines achieved for products [...]
Winter 2024 Newsletter
Before everyone signs off for the festive season, we’d like to share a few things that CIRS has been up to recently, as well as a summary of our [...]
Workshop Synopsis – Regulatory and HTA collaborative models
In this workshop, CIRS brought together senior representatives from regulators, HTA agencies, pharmaceutical companies, payers, academics and patient organisations to discuss the impact of regulatory and HTA collaborative models [...]
Frequency and Variation of Clock-Stop During EMA Assessment for Oncology Products – Implication on JCA Timelines
Objectives: The implementation act adopted for the HTA Regulation (HTAR) defined the timelines of scoping, submission and assessment and output of Joint Clinical Assessment (JCA), which will be in [...]
Is collaboration between and across regulatory and HTA agencies the answer to access challenges?
More collaborative initiatives are taking place among regulatory agencies, health technology assessment (HTA) bodies and between regulatory and HTA agencies at national and regional levels. This blog by Martina [...]
CIRS RD Briefing 96 – Review of HTA outcomes and timelines in Australia, Canada and the UK 2019-2023
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. It focuses [...]
Ngum 2024 – Evaluation of review models and timelines in the EAC-MRH
Introduction: Medicines regulatory harmonisation has been embraced by many national regulatory authorities (NRAs) to improve public health through faster availability of safe, high-quality, and effective medical products to patients [...]
Ngum 2024 – Evaluation of good review practices in the EAC-MRH
Introduction: The East African Community Medicines Regulatory Harmonisation (EAC-MRH) programme was established to address challenges faced by national regulatory authorities (NRAs) of the region. Work sharing through joint assessments [...]
Strategies for regulatory alignment in East Africa
As part of the Optimising Efficiencies in Regulatory Agencies (OpERA) programme, CIRS has been working closely with regulatory agencies in the East African Community Medicines Regulatory Harmonisation (EAC-MRH) initiative to evaluate [...]