Given the extent and unprecedented gravity of the current Ebola epidemic, WHO has established an emergency use assessment and listing procedure (EUAL) for three product streams: diagnostics, vaccines and medicines, that can be used in the current Ebola outbreak or in future public health emergencies of international concern. This procedure will ensure acceptable quality, safety and performance standards for products procured by UN agencies, and provide guidance to WHO product utilization advisory committees, national regulatory authorities (NRAs), and others involved in efforts to control public health emergencies of international concern. It is modelled on similar procedures that various NRAs have implemented for emergency use authorization within their own jurisdictions.
WHO Member States and all relevant stakeholders are invited to comment on the procedures (still undergoing internal review) until COB Friday 27 March 2015.
Comments and suggestions will be evaluated and considered for possible inclusion in the current procedures if warranted. Final versions of the procedures will be made available on the WHO website after review.
Comment on the procedures for the three product streams by following the links below:
:: DIAGNOSTICS (IVDs)
Read the Procedures document for In Vitro Diagnostics (IVDs)
Comment on In Vitro Diagnostics (IVDs)
Login name: call2015
Password: call2015
:: MEDICINES
Read the Procedures document for Medicines
Comment on Medicines
Login name: call2015
Password: call2015
:: VACCINES
Read the Procedures document for Vaccines
Comment on Vaccines
Login name: call2015
Password: call2015
vaccines and global health :: ethics and policy 