Flat pharmacovigilance fee a possibility in EU: a radical change from original proposals
This article was originally published in SRA
Drug companies in the EU could be looking at paying the European Medicines Agency a flat fee – presumably annually – to cover the agency’s responsibilities under the new EU pharmacovigilance legislation.
You may also be interested in...
EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.
Vertex is hoping for EU approval in Q4 of its cystic fibrosis triple combination therapy, Trikafta. It wants the same licence in the EU as it has in the US, where the product has already become a best seller for the company.
KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib