Over half of trial patients in EU marketing submissions are from third countries
This article was originally published in SRA
Executive Summary
Some 61% of the patients who took part in the pivotal clinical trials used to support marketing authorisation applications submitted to the European Medicines Agency between 2005 and 2009 came from third countries, a report by the agency has revealed1. In addition, since 1997, good clinical practice inspections have been requested for only 228 of the 44,034 investigator sites counted as part of the pivotal trials in these MAAs, illustrating the very small sample of sites that are, or can be, inspected.
You may also be interested in...
Kite Strikes CAR-T Access & Discount Deal For Tecartus In England
Health technology assessment body NICE wants Kite to collect more evidence to prove that Tecartus can cure relapsed or refractory mantle cell lymphoma. But in the meantime, it says the CAR-T therapy should be made available on the National Health Service, making UK patients among the first in the world to be offered access to the treatment.
New Filings At The EMA
New medicines under evaluation at the European Medicines Agency.
Migraine & Hepatitis B Prevention Products Among New EU Filings
The latest list of marketing authorization applications under review by the European Medicines Agency includes filings for eight new products.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: