Invitation to manufacturers of anti-malarial medicines to submit expression of interest to receive technical assistance for Good Manufacturing Practices

Medicines for Malaria Venture (MMV) is committed to increasing the availability of quality-assured antimalarial drugs, in line with WHO treatment guidelines. In recognition of the importance of supporting the manufacturing of medicines closer to the patient, MMV is inviting manufacturers of Active Pharmaceutical Ingredients (API) for malaria medicines and Finished Pharmaceutical Products (FPP) to submit expressions of interest to receive technical assistance to support WHO prequalification for their products.

Prequalification is a WHO programme established to apply standards of quality, safety and efficacy of medicinal products; WHO prequalification is often a requirement for international medicine tenders.  MMV has collaborated with pharmaceutical companies globally, assisting in ensuring Good Manufacturing Practice (GMP) standards are met. This support involves technical assistance preparing dossiers and in addition, developing packaging, training materials, and providing market information. This approach helps contribute to developing the manufacturers’ skill set in preparing dossiers.

Procedure for submission of expression of interest (EOI) and questionnaire

Current or prospective manufacturers of eligible malaria medicine APIs and finished products are encouraged to submit an expression of interest letter to MMV. Following an EOI submission, a questionnaire will be sent to gather information. The response will be evaluated against the selection criteria detailed below.

A short list of API and FPP manufacturers will be generated from this assessment. Subsequently, a virtual audit of the manufacturing facility may be conducted and/or a virtual meeting may be requested to provide clarification on the manufacturers’ responses. The outcome of these meetings will lead to a final selection of API and FPP companies to receive technical assistance toward WHO prequalification.

Eligible products for this program

Selection criteria

Selection will be based on the following criteria: manufacturing facilities status, quality management system maturity, successful inspection and audit history, WHO/stringent regulatory agencies status, quality control laboratory capabilities, product portfolio, business sustainability.

Opportunity for Q&A

Manufacturers who have expressed interest and who wish to submit questions prior to the submission, are encouraged to do so by sending their questions to the following email address access@mmv.org. Responses to all questions will be posted on this page for all interested companies to see. on the MMV web site.

Deadline and how to submit.

Please submit a letter of expression of interest to access@mmv.org. The deadline for submitting expressions of interest is 8 October 2023.

Expression of interest letters must be sent:

1. On company letter head, indicating the FPP and APIs that you would be interested in.
2. Specifying the point person and contact details for receiving the questionnaire and further communication.

Notes:

Submitting an expression of interest does not guarantee that the manufacturer will receive technical assistance. If required, an NDA can be provided and signed together with the questionnaire.

If required, an NDA can be provided and signed together with the questionnaire.

Q&A

Question: We only have sulfadoxine-pyrimethamine FPP available and some others are on initial development stage. Can we still express for sulfadoxine-pyrimethamine FPP as its not appearing on the Eligible product list?

Response: The technical support is focused on those products listed in the EOI and as long as the manufacturer currently has them or intends to develop one of them as part of their malaria portfolio products in the future, they can apply to the EOI.