Paediatric investigation plans

A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver.
Human Paediatrics

This requirement also applies when a marketing-authorisation holder wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorised and covered by intellectual property rights.

Also on this topic

Joint EMA / FDA guidance

Joint procedural information is available from EMA and the United States Food and Drug Administration (FDA) for medicine developers submitting a PIP to EMA and an initial pediatric study plan (iPSP) to the FDA.

For more information, see:

Cancer medicines for use in children

Given the rarity of childhood cancers, this joint guidance aims to speed up the development and authorisation of cancer medicines for children. It describes the information the two regulators typically require for their evaluations to support:

  • simultaneous submission to both regulators;
  • coordinated discussions between the regulators in the context of the Paediatric Cluster;
  • international collaboration in the design and conduct of clinical trials.

Common Commentary - EMA/FDA: Common issues requested for discussion by the respective agency (EMA/PDCO and FDA) concerning paediatric oncology development plans (Paediatric Investigation Plans [PIPs] and initial Pediatric Study Plans [iPSPs])

English (EN) (216.57 KB - PDF)

First published:
View

Stepwise PIP pilot supporting authorisation of innovative medicines

EMA is running a pilot for a 'stepwise PIP' agreement which would introduce a partial development programme supporting the authorisation of innovative medicines for children.

For more information, see:

Deferrals and waivers

The PDCO may grant PIP deferrals for some medicines. These allow an applicant to delay development of the medicine in children until, for instance, there is enough information to demonstrate its effectiveness and safety in adults.

Even when studies are deferred, the PIP will include details of the paediatric studies and their timelines.

More information on requirements for companies is available under PIP deferrals.

The PDCO may also grant waivers when development of a medicine in children is not needed or is not appropriate, such as for diseases that only affect the adult population.

Post-assessment guidance

After assessing an application for a PIP, deferral, waiver or modification, the PDCO formulates an opinion, which is notified to the applicant. The applicant is then able to request a re-examination of the opinion if it wishes. Once the Committee has issued its final opinion, after re-examination if requested, the Agency adopts a decision.

The Agency makes all opinions and decisions on PIPs, deferrals and waivers public, after deletion of information of a commercially confidential nature.

Scientific advice

Applicants can request scientific advice from EMA in preparation of a PIP, which is free of charge for questions relating to the development of paediatric medicines. 

For more information, see:

Checking compliance

Applicants must follow agreed PIPs exactly. Once the plan is complete, the European Medicines Agency or the medicines authorities in Member States check that companies comply with the agreed measures listed in each PIP.

These checks are necessary before the applicant can apply for a marketing authorisation or a change to an existing marketing authorisation.

For more information, see:

Share this page

Back to top