As the 2016 SMC campaign approaches, it is essential that all stakeholders are mobilized and are involved in the process of microplanning. This ensures the successful roll out of the SMC intervention, and in turn guarantees that as many children as possible benefit from this lifesaving treatment.
One of the key stakeholders in these preparatory stages is the National Drug Regulatory Authority (NDRA). The NDRA exists in each of the ACCESS-SMC supported countries and is the legal entity authorized to promulgate regulations and handle issues of drug policy, legislation and registration. The NDRA is the platform on which the successful delivery and use of medicines is anchored.
When not involved in decision-making or made aware of changing malaria policies and their implementation, malaria control stakeholders, such as the NDRA, are not well-positioned to play their important role in planning, implementation and monitoring. As a result, the crucial role NDRAs have in enabling deployment of medicines in countries can be compromised and health programs rendered unsuccessful.
Working with National Malaria Control Programs (NMCPs) at the start of the ACCESS-SMC Project, Management Sciences for Health (MSH) investigated the NDRA understanding of what was required of them for the success of SMC campaigns. This inquiry sought to gauge the level of collaboration for malaria control but more importantly to ensure timely execution of critical regulatory processes which otherwise would challenge successful delivery and use of SMC medicines. Key findings from the inquiry showed that collaboratively NMCPs and NDRAs was more effective in achieving registration of SP+AQ, and helped adjusting plans, guidelines and regulations to include SMC and ensure that they were consistent with policy. There was willingness and a capacity to change affected first-line treatments, the ability to collect information on safety and efficacy and aptitude to maintain the quality of medicines as they journeyed through the supply chain to eligible children.
This year, SMC campaigns will benefit from use of a child-friendly dispersible formulation of SP+AQ. While the dispersible form contains the same therapeutic ingredients, the introduction of a different dosage form requires a new application for registration. In order for SP+AQ dispersible to be registered in countries, it should already be registered in its country of origin and criteria such as proven quality, safety and efficacy are used by NDRA to pass the drug for registration. Continuing to work with NDRAs, MSH is assessing dispersible SP+AQ registration status, facilitating registration of the dispersible form, gathering evidence of registration and confirming manufacturer market authorization. All these checks will work to enable successful and timely country delivery of UNITAID-funded dispersible SP+AQ treatments in 2016.