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Overcoming the Barriers to Entry: How to Improve the Registration Process for Essential Medicines in Low- and Middle-Income Countries?

Tuesday, November 30, 2021 - 9:00am to 10:15am Eastern Time (US and Canada)

PRESENTER

  • Jane Briggs, Senior Principal Technical Advisor, Maternal, Newborn, and Child Health, USAID Medicines, Technologies, and Pharmaceuticals Services Program, Management Sciences for Health

PANELLISTS

  • Patricia Jodrey, Health Development Officer and Child Health Team Lead, USAID Bureau for Global Health
  • Kate Kikule, Principal Technical Advisor, Pharmaceutical Regulatory Systems, USAID Medicines, Technologies, and Pharmaceuticals Services Program, Management Sciences for Health
  • Murray Lumpkin, Deputy Director of Integrated Development and Lead for Global Regulatory Systems Initiatives, The Bill & Melinda Gates Foundation
  • Samuel Asante-Boateng, Head of Drugs and Nutraceutical Department, Ghanaian Food and Drug Administration
  • Prashant Yadav, Senior Fellow, Center for Global Development

MODERATOR

  • Javier Guzman, Director of Global Health Policy and Senior Policy Fellow, Center for Global Development

ABOUT THE EVENT

Ineffective and inefficient registration processes impede access to lifesaving, quality-assured essential medicines. As a result of 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, quality-assured products may not be registered or may be slow to enter in many low-and middle-income country (LMIC) markets. The absence of registered medical products gives rise to stock outs, creating voids that may be filled by substandard or falsified products, especially in countries with weak enforcement.

A variety of approaches including work sharing, reliance, harmonization, and the World Health Organization’s collaborative registration procedure have been proposed to mitigate these challenges. However, recent findings on registration of medicines for maternal, newborn, and child health published by the USAID Medicines, Technologies, and Pharmaceuticals Services (MTaPS) program suggest that these mechanisms have not been fully deployed and may not be increasing the number of registered products in practice. The current pandemic has also shown the importance of strong regulatory systems in securing access to essential quality-assured medical products, but questions remain on the best way to develop and maintain regulatory capacity in low resource settings.

Join CGD and USAID MTaPS for a conversation around how to improve national registration processes to strengthen access to essential medicines. Speakers will discuss 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 policy makers can support capacity building for efficient registration.

If you have questions for our panelists, please submit them to events@cgdev.org, tweet @CGDev #CGDTalks, or submit your comments via YouTube.

Related Experts

Director, Global Health Policy Program and Senior Policy Fellow
Photo of Prashant Yadav
Senior Fellow