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.
Bujar et al 2020 – A Process for Evaluating Quality Decision-Making Practices
Background: The development of a medicine is not only underpinned by good science but also by Quality Decision-Making Practices (QDMPs). Indeed, it is important to ensure that all organisations involved …
Rodier et al 2020 – Use of the CPP in 18 maturing markets
Background: The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing the …
Keyter et al 2020 – Can standardisation of the Public Assessment Report improve benefit-risk communication?
Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used as a …
Bujar et al 2020 – Documentation of Quality Decision-Making Practices
Background: Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into a …
Patel et al 2020 – Analysis of regulatory review timelines for ANVISA
Background: The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and quality …
COVID-19: what will be the ‘new normal’?
A number of changes to society and the economy have emerged during the COVID-19 pandemic, which are likely to impact regulators, HTA agencies and the pharma industry. CIRS recently hosted …
CIRS RD Briefing 77 – New drug approvals in six major authorities
This Briefing presents the results from the CIRS annual analysis of New Active Substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food and …
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 benchmarking …
Sithole et al 2020 – Evaluating the success of ZaZiBoNa
The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa initiative, …
CIRS RD Briefing 76 – Mexican therapeutic landscape
An efficient regulatory process can be reflected in measurable positive health impacts; conversely, activities that slow or impede regulatory efficiency and predictability can be detrimental. Recent developments in the Mexican …
Updated list of CIRS workshops
Unfortunately, given current circumstances, we have had to postpone our June workshop. Please see below for our revised list of workshops. 15-16 September, Bogota, Columbia Effectiveness of the regulatory …
CIRS RD Briefing 75 – Emergency Use Pathways (EUPs)
It has become clear that agencies have a number of pathways that can be used during public health emergencies for the authorisation of therapeutics and vaccines. Some of these so-called …
CIRS selected as Technical Partner for PQM+ programme
We’re delighted to announce that we’ve been selected as a Technical Resource Partner for the Promoting the Quality of Medicines Plus (PQM+) programme, which is funded by the US Agency …
Keyter et al 2020 – Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa
Background This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations for …
Revised list of CIRS workshops
Unfortunately, given current circumstances, we have had to postpone our March workshop. Please see below for our revised list of workshops. 11-12 June, Tyson’s Corner, USA Digital health: exploring the …