by chuck_ltd | 7 Mar, 2017 | CHCUK News & Articles, EAP, Orphan Drugs, Rare Diseases, Real Word Evidence
PRIME (PRIority MEdicines) is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of...
by chuck_ltd | 11 Jan, 2017 | CHCUK News & Articles, News, Orphan Drugs, Rare Diseases
The EU’s regulatory framework for orphan drugs is set out in Regulation (EC) No.141/2000 (the “Orphan Drug Regulation”, or ODR) and implementing Regulation (EC) No. 847/2000, and has been in force for a while now with relatively few changes. However, in recent years,...
