Background: The target product profile (TPP) outlines the desired profile of a target product aimed at a particular disease and is used by companies to plan clinical development. Considering the [...]
Background: The Gulf Centralised Committee for Drug Registration (GCC-DR), as part of the Gulf Health Council (GHC), enables the consolidated registration of pharmaceutical products throughout the member states of [...]
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 [...]
As part of the Optimising Efficiencies in Regulatory Agencies (OpERA) programme, CIRS has been working closely with the regulatory agencies who are active in ZaZiBoNa, the Southern African Development [...]
Introduction: The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to [...]
Introduction: ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall [...]
China has made significant changes to its medicine regulatory system including: Regulatory reforms - since 2015, regulatory reforms have helped to eliminate application backlogs, improve review timelines and increase [...]
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 [...]
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 [...]
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 [...]