Overview This R&D Briefing presents the Centre for Innovation in Regulatory Science (CIRS) annual analysis of new active substance (NAS) approvals by six major regulatory authorities: the European Medicines [...]
Watch Webinar Recording Join us for a webinar on regulatory reliance on Tuesday 30 June 9 AM Mexico 10 AM Colombia, Ecuador, Peru, EST 11am Chile 12 PM Argentina, [...]
This peer-reviewed publication, co-authored by researchers from the Zambia Medicines Regulatory Authority (ZAMRA), CIRS, and the University of the Witwatersrand, evaluates the quality of decision making practices used by [...]
This CIRS multi-stakeholder workshop examined strategies for embedding meaningful patient engagement and patient experience data in regulatory and HTA processes in the Asia-Pacific.
As pharmaceutical innovation becomes increasingly global, companies are pursuing multi-jurisdictional approvals and timely patient access through evolving regulatory and reimbursement pathways. In China, regulatory reforms and expanded use of [...]
The WHO Good Reliance Practices (Annex 10) provide essential principles and considerations for regulatory reliance implementation. However, it is not clear how well agencies have been incorporating these principles [...]
To mark Rare Disease Day on 28 February, we’re sharing findings from our work examining how orphan new active substances (NASs) are assessed by two of the UK’s HTA [...]
This CIRS multi-stakeholder workshop examined strategies for embedding meaningful patient engagement and patient experience data in regulatory and HTA processes.
This journal article co-authored by CIRS, AUDA‑NEPAD, the African Medicines Agency (AMA), and University of Hertfordshire, reviews the development of the African Medicines Agency (AMA), tracing its evolution from [...]
This CIRS multi-stakeholder workshop examined strategies for embedding meaningful patient engagement and patient experience data in regulatory and HTA processes.
