44TH GENERAL SESSION OF THE EUFMD COMMISSION
ONLINE 21-22-23 APRIL 2021
Proposal for the Establishment of a Standing Committee on Pre-Qualification of Vaccines against FAST diseases (SCPQv) Presenter: David Mackay, EuFMD (Appendix 15) Key Messages 1. The creation of a Standing Committee for Pre-Qualification of Vaccines (SCPQv) is proposed to oversee the operation of the prequalification system for vaccines against FAST animal diseases. 2. The Terms of Reference for the SCPQv and profile of members are proposed for endorsement 3. The committee will act as the decision-making body for the PQv procedure; decisions made by the committee will be enacted through the EuFMD Secretariat. 4. The committee will operate according to the rules for standing committees of EuFMD; in line with which the committee will nominate its own Chairperson. The committee will act by consensus and no voting is foreseen.
Summary The creation of a Standing Committee for Pre-Qualification of Vaccines (SCPQv) is proposed to oversee the operation of the prequalification system for vaccines against FAST animal diseases, with the terms of reference indicated hereafter. The committee will be required to come into operation in the third and fourth quarter of 2021 as the PQv project moves from the inception phase (2021) to the implementation (2022) and operational (2022 on) phases; The following steps are therefore proposed: - The establishment of the SCPQv, initially on an ad interim basis; The definition of membership profiles; That EuFMD will liaise with partner organizations (OIE, WHO, regulatory agencies) and Member countries to identify suitable experts that meet the profiles proposed; A proportion of the experts are recruited following a call for expression of interest from suitably qualified individuals; The composition of SCPQv is formally proposed at the next session for endorsement. The terms of reference for the SCPQv have been proposed as follows: •
To adopt formally the guidance and documentation relating to the technical requirements and procedures applicable for operation of the PQv procedure. The technical standards applied for PQv will be those described in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE);
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Review, and where appropriate formally approve, reports and recommendations from expert evaluation teams for inclusion of products onto the list of pre-qualified vaccines (the ‘PQv list’);
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Raise general or specific concerns and issues related to inclusion or exclusion of vaccines on the PQv list;
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Provide advice on request on topics referred by the EuFMD secretariat or expert evaluation teams;
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Act as an arbitration body in situations where expert evaluation teams are unable to reach a decision on listing or where manufacturers request an appeal in line with agreed procedures;
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Act as the coordination body between the nominating organizations represented on SCPQv on topics related to the quality of FAST vaccines and, where relevant, on wider issues of vaccine security; 44
