The Health and Consumers Directorate-General of the European Commission is seeking feedback from all stakeholders on a concept paper on the revision of a guideline on the format and content of applications for paediatric investigation plans (PIPs).
The consultation period for this concept paper has been extended. Comments can be sent by 3 January 2014 to or by post to the Directorate-General for Health and Consumers, Unit SANCO/D/5, BE-1049 Brussels.
The PIP guideline was released in September 2008. The Commission has initiated a review to take account of experience gained so far with PIPs as well as requests received to modify PIPs.
The purpose of this concept paper is to explore the views of interested parties on an initial proposal and identify the parts of the current guideline that should be updated.
The document includes some suggestions for amendments to the guideline from the European Medicines Agency and its Paediatric Committee (PDCO), which have been taken into consideration by the Commission in the revision process.
Since the Paediatric Regulation came into force in the European Union (EU) in 2007, pharmaceutical companies have had a legal obligation to develop PIPs as part of the development of all new medicines, unless they obtain an exemption (known as a waiver). In some cases a similar obligation also applies to medicines that are already authorised in the EU.