Expanding Effective Contraceptive Options (EECO): A Guide for Global Health Program Managers

Ensuring access to a broad range of methods is crucial in meeting the contraceptive needs of women and girls. Regulatory authorities, such as the U.S. Food and Drug Administration (FDA), are responsible for reviewing and granting or rejecting registration applications. The World Health Organization (WHO) plays a significant role in supporting access to medicines, including making it easier for manufacturers to obtain registration in multiple countries. The WHO enables more efficient registration of products through norms and standards, guidelines, and training. The WHO also offers "prequalification" (PQ) of health products, which involves reviewing and testing products to ensure they meet global standards. Regional harmonization initiatives aim to harmonize regulatory requirements and processes across countries. This can facilitate the registration of new contraceptive options in multiple markets, reducing the resource-intensive process of modifying registration applications country-by-country. The WHO Collaborative Procedure facilitates national registration of products with WHO PQ or approval from a Stringent Regulatory Authority (SRA). The Expanding Effective Contraceptive Options (EECO) project supports the introduction of new contraceptive options in FP2020 countries. EECO works with market players, stakeholders, and regulatory authorities to ensure access to high-quality contraceptives. The five stages in EECO's product introduction model are outlined, including regulatory assessment, consumer and research, procurement and quality assurance, marketing and distribution, and learning. The regulatory requirements and processes for registration are outlined, including the need for clinical trial data and clinical trials. The WHO PQ process involves reviewing and testing products to ensure they meet global standards. The WHO Collaborative Procedure facilitates national registration of products with WHO PQ or approval from a SRA. The regulatory landscape