European Medicines Agency issues reminder on PIP deferral obligations
The European Medicines Agency reminds all marketing authorisation holders that have been granted a deferral in their agreed paediatric investigation plan (PIP) that they are obliged to submit an annual report on deferred measures.
The Agency can grant a deferral to a PIP when there is insufficient information to demonstrate a medicine's effectiveness and safety in adults. A deferral allows the company developing the medicine to delay its development in children until this information is available.
The obligation to submit an annual report on deferrals is defined in Article 34(4) of the 'Paediatric Regulation' (Regulation (EC) No 1901/2006). This states that the annual report should provide an update on the company's progress with the agreed paediatric studies.