Expert Review Panel

The Expert Review Panel is a group of independent experts who review the potential risks and benefits associated with the use of finished pharmaceutical or diagnostic products and make recommendations to the Global Fund on their use. The Quality and Safety of Medicines department of the World Health Organization hosts the panel.

Two panels compose the Expert Review Panel:

  • Expert Review Panel for Pharmaceutical Products: See our Medicines page for more information on the work of this panel. The panel’s terms of reference are available below for download.
  • Expert Review Panel for Diagnostics: See Diagnostics Products for more information on the work of this panel. The panel’s terms of reference are available for download.

Opportunities for evaluation

Manufacturers are invited to submit their products for Expert Review Panel evaluation. Invitations are published as either semesterly Round calls with a submission deadline or Ad-Hoc with no specified deadline. We regularly publish all invitations on our Updates page. The continued Ad-Hoc invitations are also found in the drop down lists below:

  • Opportunities for Evaluation of Medicines

  • Opportunities for Evaluation of Diagnostic Products

Each individual invitation details the specific documents to include in a submission.  This list of documents includes, but is not limited to:

For Evaluation of Medicines:

  • An acceptance letter from the WHO Prequalification Programme confirming that the submission for the product has been accepted for review, and stating the WHO reference number assigned by WHO to this specific product or an acceptance letter from the a stringent regulatory authority confirming that the submission for the product has been accepted for review;
  • A copy of the good manufacturing practice certificate issued by a stringent regulatory authority, a member of the Pharmaceutical Inspection Cooperation scheme, or the World Health Organization Prequalification Programme certifying the compliance of the manufacturing site with World Health Organization good manufacturing practice requirements
  • Interagency Finished Pharmaceutical Product Questionnaire: This questionnaire is for the manufacturer/supplier of a pharmaceutical product to provide information to the Expert Review Panel for Pharmaceutical Products
    download in English

For Evaluation of Diagnostic Products:

  • A copy of the confirmation letter or letter of commitment that confirms the product is currently under review with the WHO Prequalification of In-Vitro Diagnostics Programme or a stringent regulatory authority.
  • A copy of the most recent inspection report proving compliance to the quality management system of either ISO 13485, WHO Prequalification or one of the regulatory authorities of the European Union, United States, Canada, Australia or Japan.
  • Diagnostic Product Questionnaire for Product Evaluation: This questionnaire assists the manufacturer in presenting the data and all requested evidence to support its submission for evaluation by the Expert Review Panel for Diagnostics
    download in English