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. 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.

Accelerated procedure for COVID-19 treatments and vaccines

EMA will review applications for agreement of a PIP, deferrals or waivers for treatments and vaccines for COVID-19 in an expedited manner, in order to speed up these products' development and approval.

The compliance check can also be expedited, if necessary.

For COVID-19 products:

  • there are no pre-specified PIP submission deadlines;
  • review of a PIP is reduced to a minimum of 20 days (from 120 days). Exact timeline depends on complexity of PIP and the preparedness by the sponsor to respond to questions;
  • EMA decision following a review is reduced to 2 days (from 10 days);
  • there is a possibility for the developer to provide a focused scientific documentation, agreed on a case-by-case basis;
  • compliance check can be reduced to 4 days.

For more information, see:

Joint EMA / FDA procedural information on submitting paediatric development plans for COVID-19 treatments and vaccines

Update: Joint procedural information is available from EMA and the United States Food and Drug Administration (FDA) for medicine developers planning to submit a PIP to EMA and an initial pediatric study plan (iPSP) to the FDA for a COVID-19 vaccine or treatment:

The joint document aims to make it easier for developers to submit paediatric development plans simultaneously to the regulators, to help speed up the development and approval of COVID-19 treatments and vaccines.

EMA and the FDA are encouraging medicine developers to submit PIPs and iPSPs early.

EMA and the FDA published the joint document on 2 June 2020.

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. They can also follow up a PIP with scientific advice, for example on combined adult and paediatric development in light of the PIP requirements.

EMA discourages applicants to submit scientific advice and an PIP applications in parallel.

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:

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