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.
Assessing the Malaysian Regulatory Process with OpERA Methodology – Mohd Sani 2025
Background: The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has partnered with the Centre for Innovation in Regulatory Science (CIRS) since 2018 to analyze the approval processes for new active [...]
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 [...]
CIRS RD Briefing 91 – Approaches to Implementing Regulatory Reliance: Considerations for Agencies
This CIRS briefing delves into the increasingly pivotal role of regulatory reliance in the global pharmaceutical landscape. Reliance is defined by World Health Organization (WHO) as the act whereby [...]
Measuring time to market for new medicines in 7 Asian countries between 2016-21, following review by US FDA or EMA
During the DIA Global Annual Meeting 2023, Adem Kermad, Magda Bujar and Neil McAuslane developed and presented a poster in which they shared the results, recommendations and conclusions about [...]
2021 Workshop report – Regulatory and HTA landscape in Asia and Latin America
As regulatory systems mature with demand for new innovative treatments, jurisdictions are seeking to introduce more comprehensive healthcare systems; this is often accompanied by efforts to initiate health technology [...]
Mohd Sani et al 2020 – Evaluation of the Malaysian regulatory process using OpERA methodology
Introduction: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides [...]
CIRS RD Briefing 72 – Trends in the regulatory landscape Asia
To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Asia are actively engaging in regulatory-strengthening and [...]
Liu et al 2013 – Characterising Good Review Practices across APEC agencies
As a first step in the implementation of the Asia-Pacific Economic Cooperation (APEC) Best Regulatory Practice Project, the Centre for Innovation in Regulatory Science conducted a gap analysis survey [...]
2011 Workshop report – Regional alignment in Asia Pacific
Regional alignment in Asia Pacific: What needs to be in the regulatory science toolkit to enable good regulatory decision making? 26-27th January 2011, Tokyo, Japan Regulatory agencies are rising [...]