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.
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 decision …
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 times …
Evaluation of the East African Community joint assessment
Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products …
Building HTA/Payer Perspectives Into Drug Development
Background: The target product profile (TPP) outlines the desired profile of a target product aimed at a particular disease and is used by companies to plan clinical development. Considering the increasing …
Evaluation of the performance of the Gulf centralised registration procedure
Background: The Gulf Centralised Committee for Drug Registration (GCC-DR), as part of the Gulf Health Council (GHC), enables the consolidated registration of pharmaceutical products throughout the member states of the …
CIRS RD Briefing 85 – New drug approvals in six major authorities 2012-2021
This Briefing presents the results from the CIRS annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food and …
Industry evaluation of the efficiency and effectiveness of ZaZiBoNa
Introduction: The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate …
Regulatory evaluation of the efficiency and effectiveness of ZaZiBoNa
Introduction: ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall median …
CIRS RD Briefing 84 – China’s evolving regulatory landscape
China has made significant changes to its medicine regulatory system including: Regulatory reforms – since 2015, regulatory reforms have helped to eliminate application backlogs, improve review timelines and increase approvals …
CIRS 2021 Annual Report
We’re delighted to present our latest Annual Report, which provides a summary of CIRS projects, publications and workshops undertaken last year as well as case studies depicting CIRS’ impact in …
2021 Workshop report – Digital technologies for clinical evidence generation
Digitisation and digital health technologies are transforming clinical development; companies, regulators and Health Technology Assessment (HTA) agencies are looking to derive actionable insights from the data being generated. This is …
2021 Workshop report – Regulatory, HTA and payer interactions and collaborations
Over the last five years, regulatory and HTA interactions, as well multi-HTA and multi-regulatory interactions and collaborations, have evolved in thinking and mutual activities both at a product level as …