CIRS RD Briefing 58: Changing regulatory environment in Latin America
The aim of this Briefing is to review and summarise the findings from the major studies and interactions carried out by CIRS in LATAM in the last decade in [...]
2015 Workshop report – Patient involvement in review and reimbursement
What is the patient’s role in informing the decision process for approval and reimbursement of new medicines? 7-th October 2015, Windsor, UK This workshop built on CIRS workshops on [...]
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 [...]
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 [...]
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, [...]
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) [...]
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 [...]
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 [...]
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 [...]