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 66 – Benefit-Risk Assessment Tool (BRAT)
A structured approach to benefit-risk assessment is required as the cornerstone of a consistent way to evaluate and communicate observations regarding a medicine’s benefit-risk profile. The Benefit Risk Action Team …
CIRS RD Briefing 65 – New approvals in six regulatory authorities 2007-2016
Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceutical companies have resulted in more new active substances (NASs) being internationalised, referring …
Quality decision-making practices
This book compiles the presentations and syndicate discussions from a CIRS workshop that brought together representatives from international pharmaceutical companiesand regulatory authorities from Europe, US, Canada and Australia and HTA …
CIRS RD Briefing 64: Review of HTA outcomes and timelines 2014-2015
Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure patient access to medicines of therapeutic value. As part of an ongoing study to monitor …
CIRS RD Briefing 63: HTA process maps
This R&D Briefing summarises the background and methodology of process mapping with examples to demonstrate the steps involved in regulatory, HTA and coverage processes for new medicines. Process maps have …
2017 Workshop report – Facilitating review through risk-based evaluations
This Workshop built on previous CIRS global development workshops as well the work being undertaken by various groups in the areas of good regulatory and review practices and focused specifically …
Globally Applicable Facilitated Regulatory Pathways to Improve Equitable Access to Medicines
A variety of approaches have been developed to accelerate the regulatory review of medicines. We characterise these various expedited pathways as facilitated regulatory pathways (FRPs): regulatory pathways designed to accelerate product …
CIRS RD Briefing 62 – New drug approvals in ICH countries 2007-2016
There have been major improvements in the regulatory environment in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries over the last …
CIRS RD Briefing 61: Building quality into decision-making processes
In 2015, CIRS initiated a programme in Quality Decision Making with the following aims: Evaluate the current decision-frameworks and understand the characteristics of different decision-making processes Assess the quality of …
Haqaish et al 2017 – Jordan Food and Drug Administration: Comparison of its Registration Process with Australia, Canada, Saudi Arabia and Singapore
Objective: This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, and …
2016 Workshop report – Commonality in evidentiary requirements
Commonality in evidentiary requirements across regulatory and HTA stakeholders 21-22 SEPTEMBER 2016, SURREY, UK Workshop objectives Discuss the progress made to align evidentiary requirements, what the drivers have been and …
CIRS RD Briefing 60 – Early scientific advice from HTA agencies
This R&D Briefing 60 summarises highlights from the Technical Forum convened by CIRS on 11 December 2015, Heathrow, UK. Forum objectives: Identify companies’ current approaches to seeking early scientific advice …
2016 Workshop report – RWD to RWE for assessing efficacy and effectiveness
Real-world data to real-world evidence for assessing efficacy and effectiveness: Opportunities and challenges for new medicines development, regulatory review and health technology assessment 23-24 JUNE 2016 TYSONS CORNER, VIRGINIA, US …
CIRS RD Briefing 59 – New approvals in six regulatory authorities 2006-2015
The last decade, 2006-2015, has seen a continuation of the convergence and general decrease in the approval times amongst six major regulatory authorities, namely the European Medicines Agency (EMA), the …
2016 Workshop report – Key performance metrics for regulatory processes
WHAT ARE THE KEY PERFORMANCE METRICS THAT AGENCIES AND COMPANIES SHOULD USE TO MEASURE REGULATORY PROCESSES AND PRACTICES TO FACILITATE THE LICENSING OF NEW MEDICINES? 3-4 FEBRUARY 2016, KUALA LUMPUR, …