This Briefing presents data from HTADock, an ongoing metrics study that collects data on new active substances (NASs) appraised by eight HTA agencies and analyses synchronisation between the regulatory [...]
This Briefing presents the results from the CIRS annual analysis of New Active Substance (NAS) approvals by six major regulatory agencies: the European Medicines Agency (EMA), the US Food [...]
An efficient regulatory process can be reflected in measurable positive health impacts; conversely, activities that slow or impede regulatory efficiency and predictability can be detrimental. Recent developments in the [...]
It has become clear that agencies have a number of pathways that can be used during public health emergencies for the authorisation of therapeutics and vaccines. Some of these [...]
CIRS has collected regulatory assessment data for over 20 years, initially with ICH and ICH-observing countries. The OpERA programme, “Optimising Efficiencies in Regulatory Agencies (OpERA)”, was initiated through CIRS [...]
Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure that patient access to medicines of therapeutic value is not delayed. As part of an [...]
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 [...]
Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure that patient access to medicines of therapeutic value is not delayed. As part of [...]
