Webinar on Public Assessment Reports (PARs)
Join us for a webinar on public assessment reports (PARs) on Tuesday 28 January 9 AM Mexico, Central America 10 AM EST, Colombia, Ecuador, Peru 12 PM Argentina, Brazil, [...]
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 [...]
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 [...]
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 [...]
Workshop Report – Vaccine regulatory and funding approaches
Over the last four years there has been much greater attention paid by industry, regulators, health technology assessment (HTA) bodies and the general public to vaccines for a range [...]
Monitoring implementation and adherence to ICH guidelines
Background: This study was built on the previous 2019 and 2021 assessments where the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) selected CIRS [...]