CIRS RD Briefing 54 – Approvals in ICH countries 2004-2013
In 2013, the overall number of New Active Substances (NASs) approved by EMA, FDA and PMDA was comparable across the three agencies. Nevertheless, despite this similarity, the number of [...]
CIRS RD Briefing 53 – Factors influencing drug roll out to six mature markets
Objective: To review NASs first launched between 2005‐2010 and to determine their regulatory status as of 31 December 2012 in USA, Europe, Japan, Canada, Switzerland and Australia to identify [...]
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 [...]
2013 Workshop report – Patient voice in clinical development
Patient voice in clinical development: Can patients contribute to the benefit-risk assessment of new medicines? 13-14 March 2013, Surrey, UK The consensus of the April 2012 CIRS Workshop, The [...]
2013 Workshop report – Ensuring quality of review decisions
Regulatory review: How do agencies ensure the quality of the decision? The role of decision frameworks in the review of new medicines: What are the challenges and solutions that [...]
Allen et al 2013 – Archetypes for non-ranking classification and comparison of European HTA systems
Introduction: European countries are increasingly utilising health technology assessment (HTA) to inform reimbursement decision-making. However, the current European HTA environment is very diverse, and projects are already underway to [...]
CIRS RD Briefing 52 – New drug approvals in ICH countries 2003-2012
Active Substances (NASs) approved by both the FDA and PMDA represented the largest number of new medicines approved this decade. Regulatory approvals by EMA were lower than the other [...]
2012 Workshop report – Building the benefit-risk toolbox
Building the benefit-risk toolbox: Are there enough common elements across the different methodologies to enable a consensus on a scientifically acceptable framework for making benefit-risk decisions? 20-21 June 2012, [...]
CIRS RD Briefing 51 – Submission lag time in the emerging markets
Lag Time (the time from which a product has been granted market authorisation in its first market to the time that its application is submitted for review by an [...]
2012 Workshop report – Patient’s role in benefit-risk assessment
The patient's role in the benefit-risk assessment for the submission and review of new medicines 25-26 April 2012, Hampshire, UK This workshop gained a perspective from various stakeholders in [...]