Adopting Minimum Common Standards for Regulatory Information Management Systems
National medicines regulatory authorities (NMRAs) are responsible for ensuring access to safe, effective, and quality-assured medical products by performing key functions as defined in the World Health Organization (WHO) Global Benchmarking Tool. In many low- and middle-income countries (LMICs), the regulatory information management systems (IMS) that support these functions are disjointed and poorly managed, not interoperable with other systems within or among countries, or even nonfunctional or nonexistent. Further, different standards for regulatory IMS exist.
The US Agency for International Development (USAID) Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program and USAID-funded Promoting the Quality of Medicines Plus (PQM+) Program conducted a series of consultations in 2021 and 2022 aimed at identifying and recommending a set of minimum common standards for regulatory IMS that will enable uniform data capture; standardize the data, design, and workflow of digitalized regulatory functions; and facilitate communication among NMRA departments and with stakeholders.
Adoption of these common standards will streamline regulatory processes and help ensure that NMRAs make technical decisions with a degree of consistency and uniformity. Minimum common standards would also enhance the ability of NMRAs to collaborate and share information with one another, including the use of reliance and recognition mechanisms. These standards should be incorporated into digitalization activities for regulatory IMS and serve as the basis for harmonizing regulatory processes across NMRAs.
Pathway to Digitalize Regulatory Information Management Systems for National Medicines Regulatory Authorities in Low- and Middle-Income Countries (also accessible through the Download button below)Download