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Extended Impact Assessment of a Draft EC Regulation on Medicinal Products for Paediatric Use
There is a serious lack of testing of medicinal products in the paediatric population. The European Commission has attempted to provide a structural solution by drafting a regulation. This report describes the economic, social, sustainable, and environmental impacts of the regulation. The assessment indicates that the proposed regulation will achieve its objectives, although the effects will vary.
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Contents
Chapter One:
Introduction
Chapter Two:
The Regulation
Chapter Three:
The Problem
Chapter Four:
Extended Impact Asssessment
Appendix:
- Evaluating implementation and outcomes
The research described in this report was conducted by RAND Europe for the European Commission.
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