Major improvements in the regulatory environment as well as changes in strategies of multinational companies have led to a decrease in the time to marketing authorisation as well as [...]
A structured approach to benefit-risk assessment is required as the cornerstone of a consistent way to evaluate and communicate observations regarding a medicine’s benefit-risk profile. The Benefit Risk Action Team [...]
Over the last decade, 2007-2016, convergence in approval times as well as changes in strategies of multinational pharmaceutical companies have resulted in more new active substances (NASs) being internationalised, [...]
This Workshop built on previous CIRS global development workshops as well the work being undertaken by various groups in the areas of good regulatory and review practices and focused [...]
A variety of approaches have been developed to accelerate the regulatory review of medicines. We characterise these various expedited pathways as facilitated regulatory pathways (FRPs): regulatory pathways designed to accelerate [...]
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 [...]
Objective: This study compares the current regulatory review process and good review practices at the Saudi Food and Drug Authority (SFDA) with those of regulatory agencies in Australia, Canada, [...]
Background The science of decision making is well established, although in reality it is a mixture of science and art. What is currently lacking is research into decision making [...]
The last decade, 2006-2015, has seen a continuation of the convergence and general decrease in the approval times amongst six major regulatory authorities, namely the European Medicines Agency (EMA), [...]
WHAT ARE THE KEY PERFORMANCE METRICS THAT AGENCIES AND COMPANIES SHOULD USE TO MEASURE REGULATORY PROCESSES AND PRACTICES TO FACILITATE THE LICENSING OF NEW MEDICINES? 3-4 FEBRUARY 2016, KUALA [...]