Over 200 million women in developing countries have an unmet need for safe and effective contraception. Hormonal contraceptive implants, introduced more than 30 years ago, are one of the most effective family planning methods developed to date. Despite their strong safety profile and popularity, their high cost has been a barrier in many countries until recently.
The Sino-implant (II) project has been at the forefront of helping to increase access to affordable, high-quality implants in resource-limited settings. As a long-acting family planning method, implants are ideal for women living in countries where access to health services is limited.
Sino-implant (II) is a highly effective, low-cost, subdermal contraceptive implant composed of two thin, flexible, silicone rods. Each rod contains 75 mg of levonorgestrel, a synthetic progesterone. The implants are inserted under the skin of a woman's arm by a trained health care provider. Annual pregnancy rates are below 1 percent, and the product is currently labeled for four years of use. Sino-implant (II) is manufactured in China by Shanghai Dahua Pharmaceuticals Co., Ltd. The product has been registered in more than 20 countries worldwide, and the manufacturing facility was deemed in compliance with WHO Good Manufacturing Practices (GMP).
FHI 360 provides technical assistance to facilitate the global introduction of Sino-implant (II), including conducting independent quality testing, negotiating public-sector price-ceiling agreements, supporting the World Health Organization prequalification application process and working with distributors to secure national regulatory approvals. FHI 360 also leads a new clinical trial in the Dominican Republic, which will supplement existing clinical evidence, and collaborates on post-marketing surveillance studies in four countries with support from the Bill & Melinda Gates Foundation and the U.S. Agency for International Development (USAID). FHI 360 works in close coordination with a number of organizations, including government officials, distributors and service delivery groups, to facilitate introduction at the country level.
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