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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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, [...]
Bujar et al 2016 – Quality of Regulatory Decision-Making Practices
Background The science of decision making is well established, although in reality it is a mixture of science and art. What is currently lacking is research into decision making [...]
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 [...]
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 [...]
Development of QoDoS tool for assessing the quality of decision making – Donelan 2016
Introduction: The impact of decision-making during the development and the regulatory review of medicines greatly influences the delivery of new medicinal products. Currently, there is no generic instrument that can [...]