Introduction: Comparisons between regulatory authorities of similar size and regulatory characteristics facilitate value-added benchmarking and provide insight into regulatory performance. Such comparisons highlight areas for improvement as authorities move [...]
Introduction: The Quality of Decision-Making Orientation Scheme (QoDoS) was developed to provide organisations involved in submission, approval and reimbursement of new medicines with a tool to improve the quality [...]
In November 2018, a collaborative forum presented by CIRS and the Utrecht University WHO Collaborating Centre for Pharmaceutical Policy and Regulation brought together regulatory, HTA, industry and academic perspectives [...]
The aim of this workshop was to bring together companies, patient representatives and HTA, payer and regulatory agencies to discuss current perspectives and opportunities for Facilitated Regulatory Pathways (FRPs) [...]
Historically, every jurisdiction with some form of regulatory agency capacity has undertaken the review of medicines as a first step in the market access process. This step is intended [...]
Objectives: To evaluate the current practice of companies and agencies to assess the changes made in aligning regulatory and health technology assessment (HTA) stakeholders; to identify areas of commonality [...]
This Workshop was a follow-on from that held in 2017 in Sao Paulo entitled “Facilitating the review of new medicines through risk-based evaluations: How can a stratification process be [...]
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, [...]