Publications
CIRS publishes insights from its research and meetings in several forms:
- R&D Briefings – research papers produced by the CIRS team e.g. annual regulatory and HTA benchmarking briefings
- Journal articles – peer reviewed academic research papers
- Reports – from CIRS workshops and externally commissioned research projects, as well as CIRS Annual Reports
- Books – research theses from CIRS-supported PhD students
- Posters – presented at external conferences
Keep up-to-date with CIRS publications and activities by signing up to our mailing list or following CIRS on LinkedIn.
CIRS RD Briefing 57 – New drug approvals in ICH countries 2005-2014
There have been major improvements in the regulatory environment in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) countries over the last …
CIRS RD Briefing 56: Understanding the dynamics of China’s regulatory environment
Changes have occurred in the organisation and procedural activities of the China Food and Drug Administration (CFDA) and the Centre for Drug Evaluation (CDE). Initiatives that were designed to improve …
2014 Workshop report – Assessment of benefits and harms and their relative importance for patients, industry and agencies
The assessment of benefits and harms and their relative importance for patients, industry and agencies: How should they be captured? 2-3 April 2014, Surrey, UK This workshop focused on the …
2014 Workshop report – Benefit-risk assessment in the post-approval period
Benefit-risk assessment in the post-approval period: How to ensure a life cycle approach to evaluating benefits and risks 12-13 June 2014, Washington DC, USA The discussion at this workshop centred …
Walker et al 2015 – Universal Framework for the Benefit-Risk Assessment of Medicines
A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, as …
Al-Rubaie et al 2014 – Evaluation of the Gulf centralised registration procedure
The aim of the study was to evaluate the Gulf Cooperation Council (GCC) centralized regulatory review process. Regulatory review times—including submission and application dates for new active substances (NASs) and …
CIRS RD Briefing 55 – Approvals across six major authorities 2004-2013
As part of the ongoing study to monitor regulatory performance, CIRS has analysed the trends in new medicines’ approval between 2004 and 2013 by six regulatory authorities including Health Canada, …
2013 Workshop report – Commonality across decision frameworks used by HTA and regulatory agencies
IS THERE A COMMONALITY ACROSS THE STRUCTURED DECISION FRAMEWORKS USED BY HTA AND REGULATORY AGENCIES? 1st-2nd October 2013, Surrey, UK This Workshop was designed to bring together the various stakeholders …
2013 Workshop report – Building quality into HTA/coverage decision-making processes
Building quality into HTA/coverage decision-making processes: What are the features of good practice in HTA? 2-3 December 2013, Heathrow, UK This workshop continued the work of the CIRS September 2011 …
2014 Workshop report – Focus on Latin America: Building quality submission and review processes and practices
Focus on Latin America: Building quality submission and review processes and practices – Overcoming challenges and meeting expectations 23-24 January 2014, Lima, Peru This workshop was held to discuss how …
2013 Workshop report – Implementing an international framework for benefit risk assessment
Implementing an internationally accepted framework for the benefit-risk assessment of medicines: How close are we to this objective? 20-21 June 2013, Washington DC, USA At the annual CIRS Benefit-Risk Workshop …
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 NASs …
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 the …
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 among …
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 Patient’s …