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 [...]
Impact of orphan designation on HTA recommendation time
In recognition of Rare Disease Day 2022, we thought we’d share some insights on the impact of regulatory orphan drug designation on the time to HTA recommendation. Regulatory orphan designation [...]
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 [...]
Where to meet CIRS – upcoming conferences
We're pleased to be involved in the following conferences coming up in the first half of 2022. Please do come and say hello! 14-16th [...]
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 [...]
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? [...]
Comparison of the registration process of Zimbabwe with Australia, Canada, Singapore and Switzerland
Background: Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients’ access [...]
Seeking early scientific advice from HTA agencies
There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, [...]
Regulatory-HTA decision-making interface: what the medical writer should know
For a new medicine to reach patients, it must achieve both regulatory marketing authorisation and reimbursement from the payer. Because regulators assess the benefits and risks of a medicine [...]
Review models and timelines in the Southern African Development Community
Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited [...]