Toolkit for the Establishment of a Medical Products Regulatory System in Small States - Volume 6

National Regulatory Authorities (NRAs) play a crucial role in ensuring that medical products used in their jurisdiction are safe, effective, and consistently of quality, whether produced domestically or imported. Access to affordable, quality medicines and medical devices and their rational use is an essential component for effective disease management, and for addressing public health emergencies, particularly infectious disease outbreaks.

The objective of this Toolkit is to provide governments of small market states with an overview of tools and steps to be used and followed in the creation or strengthening of a national regulatory system for medical products, with a particular focus on the establishment of a product registration and marketing authorization system. This Toolkit emphasizes the principles of Good Regulatory Practices (GRP), Good Reliance Practices (GReP), and the importance of the use of regionalization and reliance for small market states seeking to establish or strengthen their regulatory systems. Personnel of the Ministries of Health of small market states are encouraged to refer to this toolkit when considering establishing a national regulatory system for medical products, or when endeavoring to strengthen and enhance the capacity of an existing regulatory system.