Ministers of health throughout the Americas have endorsed a series of actions to strengthen national regulatory systems in all Member States, in order to ensure that medicines and health technologies are safe, effective and of quality, and are tailored to the needs of national health systems.
The Policy to Strengthen National Regulatory Systems for Medicines and Other Health Technologies, adopted today by the 30th Pan American Sanitary Conference of the Pan American Health Organization (PAHO) sets out a series of recommendations to strengthen governance and capacities of regulatory systems, improving regional integration and promoting convergence.
“Regulatory systems are critical for ensuring the availability of quality medicines and other health technologies, such as diagnostics and personal protective equipment, as well as for promoting equitable access to these products,” said James Fitzgerald, Director of Health Systems and Services at PAHO.
“They are also vital in enabling countries to create the necessary ecosystems for the development and production of medicines and health technologies, including current efforts to boost regional production of vaccines in Latin America, which is key to ensuring future pandemic preparedness,” he added.
The recommendations included in the Policy aim to support countries in strengthening the governance and stewardship of regulatory systems; ensure that these systems are consistent, transparent and based on best practices; improve regulatory harmonization and convergence; and adopt new evaluation systems based on the World Health Organization (WHO) Global Benchmarking Tool.
Throughout the past decade, the region has made vast improvements in the development of oversight capacity and systems, including in the designation of eight National Regulatory Authorities (NRA’s) of regional reference with the necessary installed capacities to effectively oversee and sanction the approval of pharmaceutical products.
Recent reforms within NRAs have also led to more transparent approval processes, with corresponding improvements in access to medicines and other technologies.
Despite this progress, however, significant challenges and existing asymmetries persist: “in Latin America and the Caribbean, the allocation of financial and human resources for NRAs has remained relatively static over the last five years, while the pharmaceutical market has continued to increase in value, volume and product complexity,” said Fitzgerald.
The manufacture of increasingly complex medical products also requires stronger surveillance and oversight, yet many NRAs have insufficient capacity in post-marketing surveillance or pharmacovigilance.
The new policy aims to tackle these issues, in line with the sustainable health agenda for the Americas 2018-2030, by ensuring that all Member States have robust and efficient regulatory systems in place.