Mixed Results For EMA's Early Pediatric Advice Pilot
This article was originally published in SRA
The European Medicines Agency has accepted only four of the 15 applications received so far under its early interaction pilot, which offers free scientific advice to drug companies in an effort to stimulate pediatric development1,2.
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The research-based drug industry has not minced its words in describing the problems it has faced from the EU Paediatric Regulation over the past 10 years.
The European Medicines Agency is working on plans to supplement its early advice pilot on pediatric development by providing joint advice with the US FDA and, in some cases, by arranging for a three-way dialogue with companies.
Companies are being encouraged to become “early adopters” of the EU Clinical Trials Information System when it goes live in December 2021.