Health technology assessment (HTA) has emerged as an important tool to support healthcare decision-makers to make rational reimbursement decisions, with the ultimate purpose of promoting an efficient healthcare system. [...]
PREFACE: The role of regulatory authorities in the health system is to ensure the quality, safety and efficacy of medical products. It is acknowledged that regulatory authorities are at [...]
Every regulatory authority in the world has an ambition to improve its performance. In order to achieve this, agencies often establish performance indicators which they use for measuring and [...]
This book compiles the presentations and syndicate discussions from a CIRS workshop that brought together representatives from international pharmaceutical companiesand regulatory authorities from Europe, US, Canada and Australia and [...]
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 [...]
