As numerous factors have recently contributed to changes in the regulatory environment, we have been monitoring and analysing structural regulatory issues affecting overall access to medicines in the Latin [...]
Background: The development of a medicine is not only underpinned by good science but also by Quality Decision-Making Practices (QDMPs). Indeed, it is important to ensure that all organisations [...]
Background: The certificate of pharmaceutical product (CPP) was implemented to accelerate the availability of new drugs in developing countries by providing evidence of the quality of products and reducing [...]
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 [...]
Background: Pharmaceutical companies and regulatory agencies endeavor to relate their decision making with outcomes to improve future decision making and to ensure that gained knowledge is fed back into [...]
Background: The Brazilian health regulatory agency (Agência Nacional de Vigilância Sanitária, ANVISA) has embarked on transformational initiatives to fulfill its mandate to provide timely access to safe, effective, and [...]
A number of changes to society and the economy have emerged during the COVID-19 pandemic, which are likely to impact regulators, HTA agencies and the pharma industry. CIRS recently hosted [...]
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 [...]
Introduction: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides [...]
The Southern African Development Community (SADC) collaborative medicines registration initiative ZaZiBoNa is a successful regional work-sharing initiative on the African continent. This paper reviews the history of the ZaZiBoNa [...]
