The European Commission for the Control of Foot-and-Mouth Disease (EuFMD)

Standing Committee on Prequalification of Vaccines against FAST diseases

The Standing Committee on Prequalification of Vaccines against FAST diseases acts as the oversight, governance and final decision-making committee for the PQv procedure operated by the EuFMD, to provide independent assurance of the quality of vaccines against FAST diseases. 

The SCPQv carries out the following responsibilities: 

  1. Formally adopts guidance and documentation by defining the data requirement and standards that will apply, and the procedures that applicants should follow, for operation of the PQv procedure.
  2. Review and, where appropriate, formally approve reports and recommendations from expert evaluation teams regarding inclusion of products onto the list pre-qualified vaccines (the ‘PQv list’).
  3. Provide guidance and advice to the EuFMD Secretariat for the progressive development of the PQv system, ensuring the objectives and sustainability of the system are always pursued. In this context, members will raise general or specific concerns related to the PQv list and to operational aspects of the procedure for discussion and resolution.
  4. Provide advice on request on topics referred by expert evaluation teams or by the EuFMD secretariat.
  5. Act as the arbitration body in situations where expert evaluation teams are unable to reach a decision on listing or where applicants request an appeal in line with agreed procedures.
  6. Act as the expert committee for EuFMD Member Nations on topics related to systems to evaluate the quality of FAST vaccines and, where relevant, on wider issues of vaccine security.
  7. Ensure that partner organizations and other stakeholders, particularly the manufacturers of FAST vaccines, are regularly consulted in the definition of PQv processes and in addressing issues related to vaccine security. 

The Committee is made up by experts nominated by Member Nations based on their personal expertise, and permanent observers (FAO, EuFMD, WOAH, WHO and AU PANVAC). The participation of other regional entities with relevant expertise will be ensured according to the Rules of Procedure of the Commission. 

Representatives from partners and other international organizations will act as observers to SCPQv and will contribute to topics related to the development, operation and sustainability of the PQv system, including how PQv relates to the wider objective of enhancing vaccine security for FAST vaccines.  They will not take part in decisions related to specific applications for PQv listing or appeals from manufacturers. 

Secretariat

The EuFMD will provide the secretariat to SCPQv. The Executive Secretary of EuFMD, or a nominated staff member will participate in each meeting as the formal representative for the PQv Team and will be supported by the technical and administrative staff responsible for operating the PQv procedure.