VTE encompasses both DVT and PE and is the third most common cardiovascular disease after heart attack and stroke. The growing number of rare diseases awaiting treatment are an important public health issue.
Orphan medicines legislation aims at providing incentives for pharmaceutical companies to develop and market medicinal products to treat rare diseases. A ground-breaking precedent was set by the United States in 1983 when the Orphan Drug Act came into effect.
An orphan product receives a marketing authorisation from the EMA (European Medicines Agency). The EMA provides protocol assistance (scientific advice for orphan products) in the form of scientific advice about the various tests and clinical trials necessary for drug development to pharmaceutical companies.
During the approval process fee waivers for orphan designation and reduced fees are granted.


Pharmaceutical companies developing orphan drugs may be eligible for specific grants from EU and Member State programmes as well as initiatives supporting research and development. The orphan medicines centralised procedure in Europe, from a request for orphan designation to marketing authorisation, is displayed in this document below. A social network of rare disease communities led by EURORDIS in partnership with leading disease-specific patient groups.
Join the largest gathering of rare disease stakeholders across Europe, at the biennial European Conference on Rare Diseases and Orphan Products. Often the scarcity of incentives for drug manufacturers and the lack of documentation supporting the applications limit the number of new orphan drugs. EURORDIS, representing the rare disease patient community in Europe, actively advocated for the adoption of this legislation.
1990s – Orphan Drug Legislation adopted by Singapore (1991) Japan (1993) and Australia (1997).


Competitive similar products cannot be placed on the market for 10 years after receiving marketing authorisation. This information is delivered at no cost or a reduced fee to optimise the development of orphan drugs and to ensure better compliance with the European regulatory requirements. 2000 – Creation of the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA) in London. Most advanced pharmaceutical sciences peter welling on tufts university of strenuous clinical.



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