منابع مشابه
Orphan drug legislation: lessons for neglected tropical diseases.
In the last 20 years, orphan drug legislation (ODL) has been adopted in several countries around the world (USA, Japan, Australia, and the European Union) and has successfully promoted R&D investments to develop new pharmaceutical products for the treatment of rare diseases. Without these incentives, many life-saving new drugs would have not been developed and produced. For economic reasons, th...
متن کاملA comparative study of orphan drug prices in Europe
Background and Objective: This study assessed price differences by comparing annual treatment costs of similarly available orphan drugs in France, Germany, Italy, Norway, Spain, Sweden, and UK. Methods: Annual treatment costs per drug were calculated using ex-factory prices from IHS POLI and country price databases. The treatment cost in the comparator country was compared to the UK and ratios ...
متن کاملEurope proposes laxer regulation of clinical trials.
creature known as the European Commission’s Clinical Trials Directive that apparently creates a mountain of bureaucratic red tape and overly stringent oversight, leading to an average 152-day delay in the start of trials. The consequence, many companies and researchers say, has been a substantial decline in the number of applications to conduct clinical trials in the European Union — to 3800 in...
متن کاملOptimizing an Orphan Drug Framework for Canada Canada’s Orphan Drug Framework: Lessons from the United States, Europe and Japan
Canada is in the process of developing an orphan drug regulatory framework (the “Canadian Framework”) 1 in which an orphan drug is defined as one targeting a disease that affects fewer than 5 in 10,000 Canadians. The federal government announced the development of the Canadian Framework in 2012. Health Canada has held workshops and announced pilot projects related to the Canadian Framework, but...
متن کاملThe role of globalization in drug development and access to orphan drugs: orphan drug legislation in the US/EU and in Latin America
Compared to a decade ago, nearly three times as many drugs for rare diseases are slated for development. This article addresses the market access issues associated with orphan drug status in Europe and the United States in contrast to the legislation in five Latin American (LA) countries that have made strides in this regard--Mexico, Brazil, Colombia, Chile and Argentina. Based on the success o...
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ژورنال
عنوان ژورنال: Nature Biotechnology
سال: 1998
ISSN: 1087-0156,1546-1696
DOI: 10.1038/nbt0998-814