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.
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 …
2020 Workshop report – Reimagining regulatory models
As the regulatory landscape changes to meet new challenges, such as increasingly sophisticated medical innovations, fundamental questions are being raised: What is the role of a ‘modern’ regulator today? Does …