The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials.
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
Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. It should contain company questions, justifications or company positions, and appropriate summary information.
The effect that something is likely to have on the treatment of a particular group of people, or on the results of treating that group.
In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.
Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.
A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.
A systematic evaluation of the evidence on the outcomes of different drugs or other options for treating, preventing, or diagnosing a medical condition.
The conduct and/or synthesis of research comparing different benefits and harms of alternative interventions and strategies to prevent, diagnose, treat, and monitor health conditions in routine clinical practice (i.e. the real-world setting).
Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.
A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.