Welcome to our new starters
We’re thrilled to welcome Belén, Adem and Juan to the CIRS team! As our HTA Research Analyst, Belén will be supporting core HTA projects, such as our annual HTA [...]
CIRS RD Briefing 82 – Regulatory reliance pathways: opportunities and barriers
An increasing number of National Regulatory Authorities (NRAs) are turning to reliance as a way to conserve resources, build expertise and capacity, increase the quality of their regulatory decisions, [...]
CIRS RD Briefing 81 – New drug approvals in six major authorities 2011-2020
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 [...]
CIRS 2020 Annual Report
We're delighted to present our latest Annual Report, which provides a summary of CIRS projects and workshops undertaken in 2020 as well as case studies depicting CIRS’ impact on [...]
Bujar et al 2021 – Transparency in EMA and FDA decision making
Although it cannot be expected that different medicines’ regulatory agencies always reach the same review outcome, it is important that decision making is documented and communicated to ensure transparency. [...]
CIRS RD Briefing 80 – Reimagining medicine regulatory models
This R&D Briefing summarises the outputs of breakout group discussions held during a CIRS multi-stakeholder workshop in December 2020 entitled ‘Reimagining medicine regulatory models: implementing fit-for-purpose sustainable activities for [...]
Join the CIRS team
CIRS currently has three vacancies open: Head of CIRS This position will lead the CIRS team in its mission to maintain a leadership role in identifying and applying scientific [...]
CIRS RD Briefing 79 – Use of advisory committees in Colombia
This Briefing provides an overview of how advisory committees can be used to support the regulatory decision-making process and considering the context of Latin American regulatory systems, aims to [...]
Bujar et al 2021 – Value of Facilitated Regulatory Pathways
Background: Despite the growing application of facilitated regulatory pathways (FRPs), little attention has focused on assessing the perception of pharmaceutical companies regarding their usefulness beyond increasing timeliness. Objectives: The [...]
Join the CIRS team
CIRS currently has two vacancies open: Head of CIRS This position will lead the CIRS team in its mission to maintain a leadership role in identifying and applying scientific [...]