“Overly prescriptive”, “onerous on pharmaceutical companies” and “disappointing”. These were just some of the words that the research-based drug industry used to describe its experience with the EU Paediatric Regulation in response to a consultation by the European Commission, which is due to publish a report on how the regulation is faring since it was introduced 10 years ago.
‘Not What We Expected,’ R&D Industry Says Of ‘Onerous’ EU Paediatric Regulation
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.
