The present COVID-19 pandemic and past outbreaks, such as avian influenza, SARS, and MERS, suggest that national medicines regulatory authorities (NMRAs), their regional networks, and governments were not appropriately equipped to contest with emerging infectious disease (EID) outbreaks. Given the NMRAs’ role to speed access to quality and life-saving products while safeguarding against those that may be harmful or poor quality, the lack of regulatory preparedness for public health emergencies can be catastrophic and exacerbate inequities in access to medicines, vaccines, and medical devices such as diagnostics and PPE. Moreover, it represents a failure for the national, regional, and global public health actors to act individually or collectively.
To address this failure, NMRAs, government and private disease programs, health professionals, scientists, policymakers, and the donor community need to come together to share their experience, expertise, and ideas for developing a strategic and practical pathway for countries to cope with the existing COVID-19 pandemic and prepare for future ones. One such pathway is the adoption of national expedited regulatory approval procedures that utilize regional and global reliance to speed access while ensuring sufficient quality, safety, and efficacy both before and after a product is in use.
The U.S. Agency for International Development (USAID) funded-Promoting the Quality of Medicines Plus (PQM+) program, implemented by the U.S. Pharmacopeial Convention (USP), provides technical assistance to strengthen the capacity of NMRAs in 22 low- and middle-income countries (LMICs) to improve access to quality, safe, and efficacious life-saving medical products and to assist manufacturers to bring quality life-saving medical products to market in LMICs to meet priority public health needs. PQM+’s support to national, regional, and international partners to advance common goals toward safeguarding public health has become even more crucial during the COVID-19 pandemic.
The objective of this PQM+-led session is to highlight critical considerations for equipping and preparing NMRAs for future pandemics by establishing appropriate and agile drug approval processes.