Abstract
New contraceptive products have the potential to help women and girls plan the families and lives they desire. Among the 214 million women in developing countries with an unmet need for family planning (FP), many cite method-related reasons for not using contraception. Some women want methods with different side effects, or no side effects at all. Others need discreet methods, or methods they can use while breastfeeding. Ensuring that women have access to a broad range of methods is one critical component of meeting their contraceptive needs. In almost all cases, registration of contraceptive products is a prerequisite for access.
Regulatory requirements and processes are complex, evolving, and vary by country. As a result, many global health program managers lack the regulatory expertise needed to plan for registration as a part of new contraceptive product introductions. The goal of this guide is to demystify regulatory affairs for non-experts. Readers will learn the basics of product registration and how this information can support good decision-making by program managers in consultation with regulatory experts.
To support sound regulatory strategies in places where unmet need for contraception is highest, this guide focuses specifically on Family Planning 2020 (FP2020) countries.
