Objectives Regulators must balance medicine benefits and risks while ensuring consistency, transparency, and efficiency in decision-making and the aim of this study was to assess UMBRA’s impact on SAHPRA [...]
Background: Despite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to middle-income countries. On the African [...]
Background: National regulatory authorities (NRAs) make the decision to register a medicine based on an assessment of its benefits and risks and publicly available assessment reports are used 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 [...]
A universal framework for the evaluation of the benefit-risk assessment of medicines during development by pharmaceutical companies and in the regulatory review by regulatory authorities is considered of value, [...]
CIRS authors write about benefit-risk in the March 2010 issue of Regulatory Focus by the Regulatory Affairs Professionals Society (RAPS). Article reproduced with the permission of RAPS. Download [...]
