The registration status of maternal, newborn, and child health medical products: evidence from 9 countries

Abstract

Background: Registration challenges in resource-limited countries can compromise the availability of life-saving maternal, newborn, and child health (MNCH) medical products - quality-assured generic products may not be registered or renewed. Methods: To identify barriers, we assessed the registration status of MNCH tracer medicines in 9 countries through document review and interviewed country regulators and 11 pharmaceutical manufacturers using structured questionnaires. Results: On average, 72% of the tracer medicines had at least one registered product across the 9 countries (ranging from 28% to 100%). Some countries only had one or two registered products for some MNCH tracer medicines. Five countries had not registered any of the four World Health Organization-prequalified products. The average registration timeline ranged from six months to four years due to national regulatory authority backlogs and complicated procedures. Only two countries officially recognised regulatory decisions from other countries' Good Manufacturing Practices inspections. No country had formal processes embedded in legislative provisions to prioritise and expedite registration of essential MNCH medical products. Discussion: Solutions to registration impediments involve legal, organisational, and procedural changes. MNCH medicines have specific challenges including low profit margins due to the ease of production and variety of manufacturers; additionally, an inconvenient registration process is a disincentive for manufacturers. Likewise, procurers who are more price than quality conscious may not procure costlier prequalified medicines. Registration catalysts include streamlining the process with electronic management information systems providing market information, maintaining qualified staffing, and emphasising reliance on and recognition of other regulatory authority decisions. Conclusion: Some life-saving MNCH products are not available because national registration processes are flawed. Consequently, governments and donors must invest in changes to streamline procedures to register vital medicines to protect the health of women and children. To maximise health outcomes, countries should prioritise the registration of products of public health importance, including MNCH medicines.