Improved diagnostic tests for tuberculosis case detection are urgently needed that are affordable, robust, and easy to use so that they can be implemented widely. The mandate of national regulatory authorities is to ensure the safety and effectiveness of diagnostics, protecting the population against unsafe products while expediting access to beneficial new devices. However, regulatory approval...

The "Workshop on Regulatory Use of (Q)SARs for Human Health and Environmental Endpoints," organized by the European Chemical Industry Council and the International Council of Chemical Associations, gathered more than 60 human health and environmental experts from industry, academia, and regulatory agencies from around the world. They agreed, especially industry and regulatory authorities, that ...

Medicines of uncertain quality, safety and efficacy can be worse than no treatment at all. It is the responsibility of national medicines regulatory authorities to protect patients from harm. Yet, there are great disparities in regulatory capacity globally, preventing large populations from accessing the benefits of advances in the pharmaceutical field. This article describes the main regulator...

Many of the origins of the recent financial crisis were in the United States, beginning with subprime mortgages and mortgage securities. As the crisis spread globally, few market participants or regulatory authorities saw it coming, and all underestimated its severity. In the United States, the crisis has sparked many proposals to address its perceived causes and prevent a recurrence. Proposals...

Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consist...

Evidence from low-income Asian countries shows that performance-based financing (as a specific form of contracting) can improve health service delivery more successfully than traditional input financing mechanisms. We report a field experience from Rwanda demonstrating that performance-based financing is a feasible strategy in sub-Saharan Africa too. Performance-based financing requires at leas...

At pan-European level there is a need for traceability systems giving information on origin, processing, retailing and final destination of foodstuffs. Such systems shall enhance consumer confidence in food; enable the regulatory authorities to identify and to withdraw health hazardous and non-consumable foodstuffs from the market. Animal feeds are an element in this "food-to-farm" approach to ...

A questionnaire-based survey was distributed to OIE Member Countries to assess the role of veterinarians in contemporary food safety risk management, particularly at the level of livestock producers. Almost all countries reported that food safety was a priority public health issue, and veterinarians in animal health authorities, food safety authorities, private practice, academia and industry a...

This paper describes particular aspects of the marketing of veterinary medicinal products (VMPs) that contain or consist of genetically modified micro-organisms (GMMs) or genetically modified organisms (GMOs). The regulatory requirements and the procedures applied in the European Union for each phase (pre-marketing, authorisation process, and post-authorisation labelling and monitoring) are exp...

This paper re-examines the problem of information asymmetry in the digital certificates market (Backhouse et al., 2003). It aims to discuss how market mechanisms such as rating systems may be more efficient than regulatory interventions in resolving the Lemons problem in this market. In this research, we discuss the concept of rating systems in the economics literature, and explore their value ...