In response to the imperative need for quality supplies to be available for procurement by donors, governments, and other agencies, this workstream—a collaboration between the Market Development Approaches and Systems Strengthening Working Groups—seeks to build the capacity of generic suppliers to ensure their products meet appropriate quality standards and get their products to market.

This workstream focuses on the following activities:

• WHO Pre-qualification of a range of hormonal contraceptive (HC) products from the different HC product groups (oral contraceptives, emergency contraception, injectables, implants, hormone-releasing IUS)—this workstream is housed under the SSWG.
• Under the Innovation Fund-financed AQAS Initiative, the MDAWG—with leadership from Concept Foundation—is working on the provision of technical and strategic assistance to selected generic manufacturers of HC products who are best placed to meet and maintain the standards required to achieve WHO pre-qualification. This will include adherence to CGMP, the submission of complete application and site dossiers, and documented proof of API sourcing.
• In collaboration with the SSWG, the MDAWG will design and implement a strategic plan aimed at raising the interest of generic HC manufacturers in achieving WHO pre-qualification for one or more of their products. The plan will identify strategies that will culminate in the emergence of a vigorous market for quality-assured generic hormonal contraceptive products and will identify the key stakeholders in this dynamic process—broadly, these include the generic manufacturers of hormonal contraceptives; the procurers and donors that are members of the Coalition; the national regulatory authorities, focusing on countries with generic manufacturers of hormonal contraceptives; testing laboratories; and WHO. 

Expansion of this workstream: Matters that are connected to the overall concept of quality and efficacy of reproductive health supplies may also be addressed as a logical extension of this workstream.  These matters relate to the question of counterfeit goods and their proliferation in low- to middle-income countries, especially if they are hormonal contraceptive methods.