Product Registration Toolkit: A Guide for Regulatory Experts and Non-Experts

The toolkit aims to guide regulatory experts and non-experts alike through the process of registering health products, such as contraceptives, in low- and middle-income countries (LMICs). The toolkit includes an introductory video, a primer on product registration basics, a selection of checklists, templates, and decision trees. The primer on product registration basics is designed to demystify regulatory affairs for non-experts. It provides an overview of the product registration process and offers guidance on how to make informed decisions in consultation with regulatory experts. The toolkit also includes checklists to help manage the many processes involved in product registration, ensuring that users stay organized and plan ahead. Templates of common documents required for product registration are also provided, allowing users to jumpstart the process. These templates are designed to be adaptable to different registration applications, taking into account the unique requirements of each country. Additionally, a quick reference glossary is included to help users navigate the regulatory jargon associated with product registration. The Product Registration Toolkit is a valuable resource for anyone involved in the process of registering health products in LMICs. By providing a comprehensive guide to the product registration process, the toolkit aims to facilitate the safe and effective introduction of new health products to the market. The toolkit is available for download, and users can access the full collection of resources, including the introductory video, primer, checklists, templates, and glossary. The toolkit's focus on LMICs highlights the importance of product registration in these countries, where access to safe and effective health products is often limited. By providing a clear and concise guide to the product registration process, the toolkit aims to support the development of robust regulatory frameworks and improve access to essential health products. The toolkit's adaptable resources and user-friendly format make it an essential tool for anyone involved in product registration in LMICs. The EECO project's Product Registration Toolkit is a testament to the importance of collaboration and knowledge-sharing in the field of product registration. By working together to develop a comprehensive guide to the product registration process, regulatory experts and non-experts can ensure that health products are registered safely and effectively, ultimately improving access to essential health products for those who need them most.