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.
Guidance on COVID-19 medicines is available for medicine developers and companies:
For more information, see:
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:
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:
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.
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.
For more information, see:
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: