The WHO Prequalification Program

Established in 2011, the WHO Prequalification Program serves as a global benchmark for quality, safety, and efficacy. For manufacturers, achieving prequalification is a “seal of approval” that allows their products to be procured by major international agencies.

The program actively engages with countries through its WHO Collaborative Registration Procedure (CRP). The CRP serves as a bridge between global prequalification and national market entry. Once a product is successfully WHO prequalified, the CRP allows the manufacturer to share the full, unredacted WHO assessment and inspection reports directly with national regulatory authorities. The mechanism is designed to accelerate access to SRH products while retaining country ownership: WHO provides the technical evidence; the sovereign decision to authorize the product remains entirely with the national government. This collaboration slashes registration timelines, often to within 90 days.

Below you will find the direct links to the prequalified lists.

Medicinal Products

WHO list of prequalified medicinal products

IUD

UNFPA list of prequalified IUD suppliers

Male Condom

UNFPA list of prequalified male condom suppliers

Female Condom

UNFPA list of prequalified female condom suppliers

SRH Medicines

UNFPA list of SRH medicines assessed by the CRP available for procurement

Quality as a Strategic Pillar in RHSC’s 25/35 Strategy

Good sexual and reproductive health depends on access to safe and effective supplies that meet high-quality standards. RHSC contributes to this vision by making sure that high-quality products are available in country markets and by supporting efforts to increase the efficiency of regulatory procedures at global, regional, and country levels. Over the next decade, RHSC will focus on improving the regulatory environment and building public trust in SRH products, ensuring that quality remains a central strategic pillar of supply security.

RHSC focuses on regional harmonization as a pathway for reducing registration expenses and timelines. While RHSC does not directly support individual product registrations, it is adept at engaging with regulatory mechanisms, donors, implementing partners, and other regional actors to overcome barriers to market entry.

Moreover, RHSC utilizes its neutrality to offer a safe space where the community can align around a shared definition of quality. As more countries transition to doing their own procurement systems, arriving at a consensus on quality-assurance standards has become especially important.

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