Expanding Effective Contraceptive Options: Product Registration Toolkit

Through the process of registration, these authorities review key information about the product, including clinical trial data, to determine if it should be allowed on the market. Once registration is granted, regulatory authorities continue to monitor the product throughout its lifecycle in the market. Regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, are responsible for reviewing and granting or rejecting registration applications in the countries where they have the legal authority to do so. Outside of the U.S., these authorities are commonly a branch of the Ministry of Health. Yet in some cases, the regulatory authority is an entirely separate entity. The World Health Organization (WHO) has established collaborative procedures to facilitate faster national registration of pharmaceutical products that have received WHO Prequalification (PQ) or approval from a Stringent Regulatory Authority (SRA). Products that receive approval through the WHO Collaborative Procedure can expect more streamlined registration processes at the national level for participating countries. Stringent Regulatory Authorities (SRAs) provide expertise and resources for the proper evaluation of regulated products. SRAs are defined by their status as a member, associated member, or observer of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Examples of SRAs include the U.S. FDA and Japan's Pharmaceuticals and Medical Devices Agency. The WHO supports access to essential medicines in many ways, including by making it easier for manufacturers to apply for registration in multiple countries and easier for national regulatory authorities to review those registration applications. In many Family Planning 2020 (FP2020) countries, shortages of human, technical, and financial resources weaken and slow local regulatory systems, preventing people from accessing high-quality contraceptives and other essential medicines when they need them. The Expanding Effective Contraceptive Options (EECO) project is a USAID-funded initiative that supports the introduction of new contraceptive options and dual protection methods in FP2020 countries where they are most needed. Each product in the EECO portfolio is designed to address one or more method-related reasons for non-use of contraception. The EECO project works with market players along the supply chain from product manufacturers to providers and clients, as well as the stakeholders who influence the policy environment. The EECO project's product introduction model consists of five stages: Regulatory Assessment & Product Registration, Consumer & Market Research, Procurement & Quality Assurance, Marketing, Distribution & Service Delivery, and Monitoring & Learning. The first stage, Regulatory Assessment & Product Registration, involves performing a regulatory landscape assessment, engaging stakeholders and meeting with regulatory authorities, supporting the identification of a suitable market authorization holder, and preparing the registration package, submitting, and supporting its lifecycle upon approval. 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, many cite method-related reasons for not using contraception. 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.