Overcoming the Barriers to Entry: How to Improve the Registration Process for Essential Medicines in Low- and Middle-Income Countries?
Ineffective and inefficient registration processes impede access to lifesaving, quality-assured essential medicines. Inadequate legal provisions, limited capacity within National Regulatory Authorities, and long and unpredictable registration processes, as well as low-profit margins and disincentives for manufacturers, hinder the registration of quality-assured products, especially in low and middle-income countries (LMICs). A variety of approaches have been proposed to mitigate these challenges. However, recent findings of a recent study on the registration of medicines for maternal, newborn, and child health published by the MTaPS suggest that these mechanisms have not been fully deployed and may not be increasing the number of registered products in practice.
On November 30, 2021, MTaPS Program and the Center for Global Development (CGD) co-hosted an event titled “Overcoming the Barriers to Entry: How to Improve the Registration Process for Essential Medicines in Low- and Middle-Income Countries?” on how to improve national registration processes to strengthen access to essential medicines. Speakers discussed the various strategies available, how innovations implemented for COVID-19 health products might be applied to other medicines, and how global health donors and LMIC policymakers can support capacity building for efficient registration.