Latest CIRS research posters
So far 2024 has been a busy year conference wise for CIRS! CIRS staff have presented work and/or moderated sessions at several conferences including DIA Europe, RAPS Euro Convergence, [...]
Comparison of Three Regional Medicines Regulatory Harmonisation Initiatives in Africa
Background The African Medicines Regulatory Harmonisation (AMRH) Initiative was formed in 2009 and subsequently, three regional initiatives (East African Community Medicines Regulatory Harmonisation [MRH], Southern African Development Community [SADC]/ZaZiBoNa [...]
CIRS RD Briefing 93 – New drug approvals by six major authorities 2014-2023
This R&D Briefing presents the results from the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory agencies: the [...]
Assessing the use of risk-based approaches in four major agencies
Introduction Over the last years, several regulatory agencies have developed risk-based approaches for the regulatory assessment of marketing authorisations of New Active Substances (NASs) as strategies to efficiently use [...]
CIRS RD Briefing 94 – Value of Reference Agency Reports in Enabling Reliance
Access to information, including the assessment documents of reference national regulatory agencies (NRA), is a key enabler of regulatory risk-based decision making. It promotes an understanding of what was [...]
What is needed for risk-based approaches to work effectively and efficiently?
In this workshop, CIRS brought together senior representatives from regulatory agencies, pharmaceutical companies and academia from 18 countries across the Americas, Africa, Asia and Europe, to examine risk-based approaches [...]
CIRS RD Briefing 92 – Appraising the usability of public assessment reports for reliance
Regulatory reliance facilitates regulatory approvals, allows the use of resources more efficiently, and ultimately serves patients by accelerating access to quality-assured, safe, and effective medicines. The World Health Organisation [...]
2023 Workshop report – Review and reimbursement frameworks for rare disease products
There are an estimated 300 million people across the world affected by around 7000 known rare diseases. Challenges in bringing treatments to market for these conditions include small patient [...]
Webinar on approaches to implementing regulatory reliance
We recently presented key findings from our latest R&D Briefing in a webinar on 'Approaches to Implementing Regulatory Reliance: Considerations for Agencies'. The webinar was attended by over 200 people [...]
2023 Workshop report – Uncertainty in the development of new medicines
This CIRS workshop brought together companies and agencies (HTA and Regulatory) to discuss the sources of uncertainty that are being built in, by the way medicines development has evolved [...]