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‘Not What We Expected,’ R&D Industry Says Of ‘Onerous’ EU Paediatric Regulation

 
• By Vibha Sharma

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.

Papers
The EU Paediatric Regulation Has Introduced An Unnecessary Degree Of Bureaucracy • Source: Shutterstock

“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.

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