Invitation to manufacturers of Diagnostics Products to submit an
Expression of Interest (EoI) for product evaluation by the Global
Fund (GF) Expert Review Panel for Diagnostics Products (ERP-D)
Scope of the EoI: Rapid Diagnostic Tests (RDTs) for HCV, G6PD deficiency, HIV rapid
test for self-testing and for HIV molecular tests using Dried Blood Spot (lab-based or POC)
Date of this EoI: 26.02.2016
Closing date for Receipt of EoI: 26.04.2016
EoI Reference No: GF/ERP-D/Round 4/02-2016
 Background The Global Fund to Fight AIDS, Tuberculosis and Malaria (the “Global Fund”) and UNITAID
support the procurement of large amounts of diagnostics and related laboratory items for the
diagnosis and management of HIV/AIDS, tuberculosis and malaria. In March 2011, the Global Fund
(GF) introduced a Quality Assurance Policy for Diagnostic Products (“QA Policy”). The QA Policy
primarily focused on HIV and malaria rapid diagnostic tests (RDTs). After two years of
implementation, the QA Policy for Diagnostics has been revised, including quality criteria for HIV
virological and CD4 technologies. This has resulted in the operationalization of the Expert Review
Panel for Diagnostics (ERP-D) as described in the revised QA Policy1.
The ERP-D is a mechanism to review the risks associated with procurement of diagnostic products
that may have a high public health impact, but have not yet undergone a stringent assessment, either
by WHO Prequalification of In Vitro Diagnostics Programme or by a stringent regulatory authority of
a founding member of the Global Harmonization Task Force (GHTF) (i.e., USA, Japan, EU, Canada,
and Australia). The ERP-D is not intended to replace the prequalification programme of the World
Health Organization (WHO) or stringent regulatory assessment, but to provide an interim solution
for a time-limited period, in anticipation of the completion of a stringent review process. Thus, the
ERP-D mechanism may help to expedite access to innovative diagnostic products, if the associated
risks are deemed less than the potential benefits.
Among innovative diagnostics of potential interest for the countries supported by the Global Fund,
UNITAID and stakeholders, Diagnostics Products highlighted in the present EoI have been identified
as a priority for ERP-D Round 4 consideration. Access to these diagnostics products is of critical
importance, especially when market entry may be delayed due to the comprehensive reviews
associated with licensing after stringent regulatory assessment or WHO Prequalification of in Vitro
Diagnostics Programme.
The Global Fund and UNITAID issue an Expression of Interest (EoI), inviting manufacturers of
particular diagnostic category of products to submit their information for review.
1
Available at: http://www.theglobalfund.org/documents/psm/PSM_QADiagnostics_Policy_en/
GF/ERP-D/Round 4/02-2016
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Upon acceptance of an application by the Global Fund, an independent panel of technical experts
conducts an analysis of the potential risks and benefits linked to the procurement of Diagnostic
Products not yet WHO prequalified, or licensed after a stringent regulatory review.
The main product attributes used by ERP-D expert as a basis for assessing the risk of using the
products are:

Status of the Quality Management System (QMS) of the manufacturing site,


Implementation of risk management principles and activities product realization,
Performance specification, verification and validation studies: analytical, clinical
and stability studies,
Labelling, including Instructions for Use, suitability of the product for the setting
of intended use, customer support.

The ERP-D is hosted by WHO, and operates in accordance with its terms of reference. The ERP-D
then advises the Global Fund, UNITAID and other partners, as relevant, on the use of grant funds for
procurement of such Diagnostic Products for a time-limited period.
The complete process starting with the invitation to submit an expression of interest, followed by the
submission of the diagnostic product questionnaire by the manufacturers and leading to the ERP-D
review and communication of the results to the manufacturers, takes a maximum of six months.

Purpose of this invitation for Expression of Interest (EoI) The purpose of this Expression of Interest (EoI) is to invite manufacturers to submit to the ERP-D to
determine the acceptability for procurement of their Diagnostic products falling into the scope of
product categories as described in Section 3 of this document. This invitation applies only to
Diagnostics products (e.g. test reagent kits) that can (1) at least provide qualitative results at clinical
decision points, and (2) which are not yet WHO Prequalified or authorized for use through a
stringent regulatory review (defined as performed by the regulatory authority of a founding member
of the Global Harmonization Task Force (GHTF), i.e. USA, Japan, EU Countries, Canada, and
Australia)2.

Diagnostics Product categories included in the present EoI The Diagnostics Products included in the present invitation for EoI for Diagnostic products
proposed for ERP-D review should present the following specifications:

2
For HCV Diagnostic test;
-
Serological tests
-
Tests using a rapid test format and/or technologies that can be used at or near to pointof- care (POC)
This definition for a stringent regulatory authority prevails in the whole document
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
For Diagnostic test for G6PD deficiency;
-

Tests using a rapid test format and/or technologies that can be used at or near to pointof- care (POC) for G6PD deficiency in support of radical cure of patient with plasmodium vivax
For HIV rapid test for Self-testing;
-

Tests using a rapid test format and/or technologies that can be used by a person who
wants to know their HIV status, collect his or her specimen, perform the test and read
their results in a setting of their choice, such as a home environment
For HIV molecular tests using dried blood spots;
-
Point-of-care or laboratory-based HIV molecular technologies supported by a validated
protocol for dried blood spots, providing either a qualitative result (HIV EID) or a
quantitative viral load (VL) result for diagnosis and monitoring of anti-retroviral
treatment,
4. Eligibility criteria The following criteria are required to be fulfilled by the manufacturer in order to be accepted for
ERP-D review.
i. The Diagnostic Product has a dossier already under review by WHO
Prequalification of in Vitro Diagnostics Programme or is undergoing a stringent
regulatory approval process;
OR
The aforementioned product has not yet been submitted to the WHO Prequalification or has
not yet been approved by a stringent regulatory authority but the manufacturer has signed a
Letter of Agreement either to (1) submit to the WHO Prequalification of In Vitro Diagnostics
Programme or (2) engage in the regulatory approval process through one stringent regulatory
authority after a successful ERP-D review.
AND
ii.
The aforementioned product is manufactured at a site that is compliant with the
requirements: ISO 13485:2003 or an equivalent quality management system recognized
by an appropriate body (e.g. recognized certification body by a stringent regulatory
authority or successfully assessed by WHO Prequalification);
AND
iii. Any part of the Diagnostic Product for which section 4.ii above does not apply, must be
manufactured at a site compliant with all applicable requirements of the ISO 9000
series.
5. Submission of documents for ERP‐D review All manufacturers interested in submitting applications for review by the ERP-D are requested to
submit the following information and material for each of Diagnostics Products proposed for
review:
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
A cover letter expressing interest to submit the product to the ERP-D for review and indicating
the authorized contact for the manufacturer;

When appropriate, a letter from the WHO Prequalification of In Vitro Diagnostics Programme
or a stringent regulatory authority confirming that the submission for the said diagnostic
product is currently under review for the intended use or in the absence of such a confirmation
letter, a letter of commitment from the manufacturer;

One of the following document substantiated by the most recent inspection reports:
i.
A ISO 13485:2003 certificate, or
ii. A certificate ensuring that the product (reagents and equipment) is manufactured at a site
that is compliant with ISO 13485:2003 requirements, or
iii. an equivalent quality management system recognized by a stringent regulatory authority,
or
iv. a letter from WHO ensuring that the manufacturing site has been inspected by the WHO
Prequalification of In Vitro Diagnostics Programme and found compliant with WHO
prequalification requirements

A completed product questionnaire as per generic instructions outlined in the Template
document posted on the GF webpages3.
6. Confidentiality The information provided with the submission will be received by the Global Fund and shared with
the ERP-D members for the purpose of facilitating their review of the submission and provision of
advice to the Global Fund.
Information provided by manufacturers, review findings and advice provided by the ERP-D, in
connection with this EoI will be shared with and used by the Global Fund, UNITAID and the
following partners (Médecins sans Frontières, UNICEF, and USAID) for taking procurement
decisions.
7. Eligibility of the submission Completeness of the documents submitted to Global Fund Secretariat for ERP-D review is screened
by the QA officer. All documents indicated in section 5 and specifically detailed in the Diagnostic
Product Questionnaire must be sent by the applicant. Incomplete submissions will not be forwarded
to ERP-D for review.
The eligibility of the submissions for the ERP-D review will not be considered by the Global Fund
Secretariat. It is the ERP-D's responsibility to review the submitted documentation and to decide
whether or not to perform the risk benefit assessment.
3
Available at: http://www.theglobalfund.org/en/healthproducts/information/
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8. Manufacturers Commitment Manufacturers whose products receive a successful ERP-D review will be encourage to submit their
products to WHO Prequalification of in Vitro Diagnostics Programme or to a stringent regulatory
authority, if these products are not yet submitted for review, before the end of the time-limited
period recommended by the ERP-D.
9. Instructions for submission to the applicant and deadline Submission should be submitted by electronic means (CD or USB key) together with a hard copy of
the documentation set. Files should be named to reflect their content as mentioned in this letter (e.g.
“Cover letter.pdf”).
The deadline for submission is 26th April 2016.
Submissions, should be sent by mail, referring to the present EoI, to the following address:
Dr Alain Prat
Quality assurance Specialist
The Global Fund to Fight AIDS, Tuberculosis and Malaria
Chemin de Blandonnet 8, 1214 Vernier
Geneva, Switzerland
Tel: +41 58 791 1977
Email: Alain.Prat@theglobalfund.org
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