EMA Publishes Policy on Changing Scope of PIPs
The new policy allows the scope of a previously agreed PIP to be extended or merged if the company wishes to apply for marketing authorisation for more than one condition at the same time.
The European Medicines Agency has published a policy on changes in the scope of paediatric-investigation-plan (PIP) decisions, to address problems encountered by companies making changes to their development plans.
The new policy allows the scope of a previously agreed PIP to be extended or merged if the company wishes to apply for marketing authorisation for more than one condition at the same time. It also allows companies to reduce or split a PIP if it intends to apply for fewer conditions than originally planned.
The policy also addresses related issues, such as the impact of these changes on the PIP leading to the reward and the validation of applications for a new indication that may already be covered by an existing PIP condition. It illustrates these issues with examples
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