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.
Paediatric investigation plans:
- include a description of the measures to be carried out in children with the medicine;
- describe the measures to adapt the medicine's formulation to make its use more acceptable in children, such as use of a liquid formulation rather than large tablets;
- cover the needs of all age groups of children, from birth to adolescence;
- define the timing of measues in children compared to adults.
Pharmaceutical companies should submit proposals for PIPs to the European Medicines Agency's Paediatric Committee (PDCO). This Committee is responsible for agreeing or refusing the plan. The Paediatric Regulation requires PIPs to be submitted to the Agency early.
- For information on how to apply for a PIP, see PIPs: questions and answers.
The development plan for a medicine can be modified at a later stage as knowledge increases. Modifications can also be made if the applicant encounters such difficulties with the implementation of a PIP, which render it unworkable or no longer appropriate. Applicants need to apply to the PDCO for these modifications.
The Agency also develops standard PIPs to help applicants obtain the agreement for PIPs on specific types or classes of medicines. Adhering to the principles and key binding elements contained in a standard PIP will facilitate the PIP approval process.
A searchable list of opinions and decisions on PIPs is available.
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.
- For information on how to apply for a PIP deferral or waiver, see PIPs: questions and answers.
- For information on the classes of diseases subject to waivers, see Class waivers for PIPs.
- Approved deferrals and waivers are included in the searchable list of opinions and decisions on PIPs.
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.
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.
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:
- Paediatric requirements for marketing-authorisation applications
- Paediatric requirements for variations and extensions to marketing authorisations
- PIPs: Questions and answers
- Standard PIPs
- Paediatric formulations
- Class waivers for PIPs
- PIPs: Templates, forms and submission dates
- Mailing list for PIPs
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- Policy on the determination of the condition(s) for a paediatric investigation plan (PIP) / waiver (scope of the PIP / waiver) (2012-09-25)
- European Medicines Agency policy on changes in scope of paediatric-investigation-plan decisions (2013-05-08)
- Re-examination procedure of paediatric investigation plan and / or waiver opinions by the PDCO (2015-01-21)
- Standard operating procedure for modification of an agreed paediatric investigation plan (2015-10-09)
- Standard operating procedure for re-examination of Paediatric Committee opinions (2015-10-09)
- Standard operating procedure for paediatric investigation plan from re-start of procedure (after clock-stop) to PDCO opinion (2015-10-09)
- Standard operating procedure for European Medicines Agency decision-making process for decisions on Paediatric Committee opinions (2015-10-09)
- Better medicines for children (2015-05-18)
- Bridging the gap: A review of dose-investigations in paediatric investigation plans
- Pediatric formulation issues identified in paediatric investigation plans
- Scope of the PIP in the EU: easier accessibility to the paediatric rewards and simplification of administrative requirements
- Writing applications for paediatric investigation plans and waivers
- Role of modeling and simulation in pediatric investigation plans
- The development of medicines for children
- Paediatric investigation plans for pain: painfully slow!