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,...
by chuck_ltd | 18 Nov, 2015 | CHCUK News & Articles, Consultation, GCP, News
Public consultations on NOTICE FROM THE COMMISSION ON ASPECTS OF THE APPLICATION OF ARTICLE 3, 5 AND 7 OF REGULATION (EC) NO 141/2000 ON ORPHAN MEDICINAL PRODUCTS The European Commission is proposing to review the 2003 Communication on orphan medicinal products to...
