Possibly the highest level of medicine-like health claim that can be made on a non-drug product. It describes the propensity for the product or dietary ingredient to aid in the reduction of the risk factors associated with particular diseases.
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
The European network for Health Technology Assessment is a network of government-appointed organizations from European Union Member States, the European Economic Area and accession countries as well as a large number of relevant regional agencies and non-for-profit organizations that produce or c
A harmonized application form is used for clinical trial applications across the European Union.
The submission of data on medicines by marketing-authorisation holders into the EVMPD is a legal requirement from the 2010 pharmacovigilance legislation.
Electronic or paper filing system which must contains all study documents and at least essential documents as described in ICH E6.
Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.
As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are accurate, and that the rights, integrity, and confidentiality of trial subjects ar
A logical mathematical framework demonstrating the quantitative relationship between a defined set of variables (e.g. cost, effectiveness, net benefit) based upon an explicit set of parameters and assumptions.
Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to fulfil FDA requirements for an NDA or BLA in the US.
A medicine that contains an active substance or combination of active substances that has not been authorised before.