Patient Involvement in the Asia Pacific – 2026 Workshop Report
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.
Good Review Practices at the Zambian Medicines Regulatory Authority
Good Review Practices (GRevPs) are an important component of regulatory systems strengthening and support progress in World Health Organization (WHO) Global Benchmarking Tool (GBT) assessment. This poster was presented [...]
From vision to reality: Two decades of progress in global drug development and regulatory innovation
Twenty years ago, participants at a CIRS workshop explored ideas that at the time appeared ambitious, including rolling reviews, facilitated regulatory pathways, collaborative assessments and real-time data sharing. Many [...]
African Medicines Agency (AMA): Origins, Evolution and Future Prospects
This poster was presented at DIA 2026 and examines the development of the African Medicines Agency (AMA), tracing its evolution from the African Medicines Regulatory Harmonisation (AMRH) Programme to its [...]
CIRS RD Briefing 106 – New drug approvals by six major authorities 2016-2025
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 [...]
Webinar on Innovative Approaches to Regulatory Reliance
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, [...]
Evaluation of decision making practices at ZAMRA – Chisha 2026
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 [...]
Patient Involvement in the Asia Pacific – 2026 Workshop Synopsis
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.
CIRS RD Briefing 104 – Class 1 Innovative Medicines Approved in China: An International Comparison
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 [...]
Developing a mechanism to monitor regulatory reliance globally
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 [...]