EMA Director-Nominee Guido Rasi Brings Track Record For Repairing Regulatory Agency Reputation
This article was originally published in The Pink Sheet Daily
Rasi leads the Italian Medicines Agency, an agency also known for conditional reimbursement agreements.
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The EMA has announced a major restructuring plan to better aid its stakeholders, but tight staffing levels and budget stagnation could hamper the effort.
European Commission intervention has stopped duplicate generic applications. EMA hopes to end its budget row with the EU Parliament by focusing on transparency and conflict of interest disclosures.
EMA’s biosimilars interferon beta guideline, which says that magnetic resonance imaging of disease lesions may be enough to demonstrate similarity. More important perhaps, it’s the first guidance issued under the watch of new EMA chief Guido Rasi, who strongly supports allowing single data package for EU and U.S. biosimilar medicines.