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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
The Regulation (EU) 2021/2282 on health technology assessment (HTAR) reflects a significant step towards harmonising the clinical assessment in HTA decision making across EU Member States. It aims to [...]
In this workshop, CIRS brought together senior representatives from the international pharmaceutical industry, regulatory agencies, National Immunisation Technical Advisory Groups (NITAGs), HTA agencies, payers and academia to identify challenges [...]
A new report from the NASEM Health and Medicine Division offers recommendations for enhancing rare disease drug development. CIRS is delighted to have been able to collaborate with NASEM [...]
“This book teaches us important lessons that we will need to consider in our collaboration work with the African Medicines Agency. I am confident that this research will be [...]
In this workshop, CIRS brought together senior representatives from HTA agencies, pharmaceutical companies, payers and patient organisations to discuss their readiness for the EU HTA Regulation (HTAR) being applied [...]
