Objective To compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016. Design [...]
Background: According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Articles of Association, the regulatory members of ICH are expected to implement [...]
In June 2019, the Centre for Innovation in Regulatory Science (CIRS) held an Executive Colloquium in Rockville, MD, USA that brought together representatives from multinational pharmaceutical companies to gauge [...]
To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Latin America are actively engaging in regulatorystrengthening [...]
To address the complex challenges in the global regulatory environment and the growing demand for patient access to new medicines, regulatory agencies in Asia are actively engaging in regulatory-strengthening and [...]
Major improvements in the regulatory environment as well as changes in strategies of multinational companies have led to a general decrease in the time to marketing authorisation and improved consistency [...]
There is a growing interest in aligning accelerated regulatory pathways with flexible access and reimbursement pathways to expedite the equitable availability of high-quality, safe, and effective medicines that provide [...]
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 [...]
