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 in Europe.
Parallel Consultation (PC)
As of July 2017, EUnetHTA and the EMA offer parallel consultations on evidence generation plans. This multi-stakeholder procedure, in which Regulators through the Scientific Advice Working Party (SAWP) and health technology assessment bodies (HTABs) work as equal partners, aims to allow medicine developers to obtain feedback from both regulators andHTABs on their development plans to support decision-making on marketing authorization, health technology assessment, and reimbursement of new medicines at the same time.
There is one single procedure for Parallel Consultation which lasts 135 days from the submission of the letter of Intent by the Applicant to the finalisation of the Regulators and HTABs’ recommendations.. The EMA Scientific Advice (SA) Secretariat and EUnetHTA Early Dialogue (ED) Secretariat should be notified simultaneously by the Applicant 2 months prior to the formal procedure start date. The EUnetHTA ED Secretariat facilitates closed HTAs interactions for discussion of respective HTA body positions and HTA coordination throughout the procedure.
A Scientific Officer from EMA is appointed to the procedure. On the HTABs’ side, the EUnetHTA ED Secretariat contacts HTABs to request a response regarding their participation to the procedure. After receipt and validation of the Applicant’s request, on the EUnetHTA side, the Early Dialogue Working Party (EDWP) scrutinizes the request and according to established EDWP criteria, one of the two possible pathways for HTA involvement (consolidated or individual parallel consultation) is decided.
Indeed, there are two different pathways for HTA involvement the consultation can take:
Then, the final decision on the parallel consultation pathway and final composition of the Early Dialogue Committee (EDC) are communicated to EMA and Applicant.
For all Parallel Consultations, there is a presubmission phase (with or without a presubmission teleconference), which starts when the Applicant sends the draft briefing package to EMA and EUnetHTA. Comments are provided to the Applicant to optimise and finalise the briefing package before final submission and validation by both EMA and EUnetHTA ED Secretariat.
The Evaluation phase consists in :
- issuing a list of issue to facilitate the discussion during the face-to-face meeting. Regulators and HTABs proceed with their own assessment and exchange draft lists of issue before the final list of issue is sent to the Applicant. The Applicant can be requested to provide written responses before the face-to-face meeting;
- the organisation of pre-face-to-face teleconferences between Regulators and HTABs, to exchange upon and understand respective positions of both sides ;
- the preparation and attendance to the face-to-face meeting between the Applicant, Regulators and HTABs. This meeting aims at discussing issues of concern or disagreement or convergence from Regulators and/or HTABs and potential solutions that could facilitate one trial design or at least one development plan
Finally, the Final Advice Letter is adopted by Regulators and sent to the Applicant and EUnetHTA ED Secretariat while EDC Written (individual or consolidated, depended on the pathway decided) recommendations are finalised on the HTABs’ side. EUnetHTA ED Secretariat sends the Final Written Recommendations to EMA and the Applicant as a final deliverable.
The advice provided by each stakeholder is not legally binding. EMA Regulators take the Committee for Medicinal Products for Human Use (CHMP) Scientific Advice/Protocol Assistance provided into consideration during the Marketing Authorisation Application (MAA). The Applicant needs to justify fully any deviations from the advice given.
Latest Glossary Definitions
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Care delivered by a healthcare provider for a specific patient which should correspond to the care that an averagely competent physician in the same field would provide under similar circumstances.
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