Publications
CIRS publishes insights from its research and meetings in several forms:
- R&D Briefings – research papers produced by the CIRS team e.g. annual regulatory and HTA benchmarking briefings
- Journal articles – peer reviewed academic research papers
- Reports – from CIRS workshops and externally commissioned research projects, as well as CIRS Annual Reports
- Books – research theses from CIRS-supported PhD students
- Posters – presented at external conferences
Keep up-to-date with CIRS publications and activities by signing up to our mailing list or following CIRS on LinkedIn.
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 publications …
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 and …
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 parallel …
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 Garau …
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 on …
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 and …
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 and …
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 of …
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 to …
Workshop Report – Ensuring efficient and effective implementation of joint clinical assessment (JCA)
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 improve …
2024 Workshop Synopsis – Evolving regulatory and funding approaches for vaccines
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 and …
Regulatory processes for rare disease drugs in the US and EU: National Academies study supported by CIRS
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 and …
Role of Regional Initiatives in the Operationalisation of the African Medicines Agency: Contribution of the EAC-MRH Initiative
“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 extremely …
2024 Workshop Synopsis – Ensuring efficient and effective implementation of joint clinical assessment (JCA)
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 from …