A paediatric investigation plan or PIP is a requirement for any marketing authorisation application in Europe (EU, Switzerland and UK). Even in cases where the medical condition targeted may benefit from a class waiver, any company planning a market launch in Europe needs to prepare a PIP in advance and have it agreed upon before MAA submission. This does not imply that clinical studies in children need to be completed before the date of the initial marketing authorisation submission, but rather that commitments are clearly stated and agreed between Sponsors and Agencies.
Considering the similarities between the EU and UK PIPs, sponsors generally submit an initial PIP to EMA. Approval, or to be more precise, adoption of the PIP by EMA takes around 6 to 9 months on average, depending on the complexity of the dossier, with rounds of back and forth from Agency’s questions. Once the EU PIP has been settled with EMA, the plan would then be adapted to the UK MHRA PIP format and submitted to the UK Medicines Agency (MHRA). This sequence generally allows for a faster MHRA review and decision, although the MHRA may raise questions during its own independent assessment, leading to extended timelines. The MHRA doesn’t currently publish metrics related to PIP assessment timelines and there is no formal PIP statutory timeline. In our experience, PDCO agreed-upon PIPs are agreed upon faster by MHRA than brand new PIPs.
It is also possible, and sometimes advisable, to reach out to either EMA or MHRA for paediatric advice in advance of the PIP submission. in specific instances where the paediatric population is very relevant in the condition or indication sought, the advice may be particularly valuable and save sponsors precious time and resource as opposed to exchanging multiple rounds of extensive comments during the formal PIP procedure.
PIP decisions by foreign authorities, like EMA or FDA (PSP) are generally accepted by SwissMedic in Switzerland without a separate assessment.
It needs to be clarified that Paediatric Plans have separate routes of submission for each of the 3 country Agencies mentioned above (EU, UK and Switzerland) and the format of the application differs. EU and UK do not require eCTD submissions, but rather submission via Agency portals, whereas SwissMedic requires eCTD submission of the foreign Agency decision.
Pharma Design Ltd. has extensive experience with PIPs across all three countries/regions mentioned above and has prepared and submitted several PIPs for different indications/conditions through Agency portals.