Globally, 225 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) initiative 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 and is marketed under the global brand name Levoplant. 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. Sino-implant (II)/Levoplant 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 is deemed in compliance with World Health Organization (WHO) Good Manufacturing Practices (GMP). In November 2016, the United Nations Population Fund (UNFPA) approved Sino-implant (II)/Levoplant for purchase by its country programs through the WHO Expert Review Panel process. In June 2017, the product was prequalified by WHO. WHO prequalification will now allow additional donors to purchase the product for country programs; registrations at the national level are currently being updated.
FHI 360 provides technical assistance to facilitate the global introduction of Sino-implant (II)/Levoplant, including conducting independent quality testing, negotiating public-sector price-ceiling agreements, supporting the WHO prequalification application process and working with distributors to secure national regulatory approvals. FHI 360 also leads a clinical trial in the Dominican Republic, which will supplement existing clinical evidence, and collaborated 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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