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 [...]
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 [...]
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, [...]
Timely recommendation for drug reimbursement by health technology assessment (HTA) agencies is critical to ensure patient access to medicines of therapeutic value. As part of an ongoing study to [...]
This R&D Briefing summarises the background and methodology of process mapping with examples to demonstrate the steps involved in regulatory, HTA and coverage processes for new medicines. Process maps [...]
