“During the pandemic, we have watched the rapid deployment of clinical trials, the introduction of new and repurposed treatments, and now the development and use of new vaccines, many based on innovative and groundbreaking technological platforms,” said PAHO Assistant Director Jarbas Barbosa. “Throughout these processes, the role of regulatory authorities as independent and science-based institutions has proven more critical than ever.”

The report shows that national regulatory authorities vary dramatically in their capacity to evaluate medicines and medical products. The report draws lessons for improvement from six national regulatory authorities in the region, which PAHO has designated as National Regulatory Authorities of Reference (NRAr). These authorities are ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), INVIMA (Colombia), CECMED (Cuba), and COFEPRIS (Mexico).

Key findings include:

• Robust regulatory capacities result from expansive legal and organizational frameworks, which give NRArs technical independence and strong mandates to supervise and sanction the pharmaceutical product approvals within their jurisdictions.
• Recent reforms in national regulatory authorities have brought important improvement in access to medicines and transparency within the authorities.
• Financial and human resources for national regulatory authorities have remained relatively static over the last five years in Latin America while the pharmaceutical market has increased both in value, volume and medical product complexity.
• The manufacture of increasingly complex medical products requires stronger surveillance and control. Post-marketing surveillance and pharmacovigilance is a potential weakness of systems.
• Advances in national regulatory authorities have helped catalyze improvements in other countries and regions. The creation of the Caribbean regulatory system and the Central American joint working system reflect an improvement of regulatory capacity.

The report raises concerns about the “limited or complete lack of legal and organizational frameworks for regulatory systems in a number of countries.”  It encourages countries with less capacity to rely, whenever possible, on evaluations and approvals already completed by one or more of the NRArs.

The report also highlights emergency measures that authorities have implemented since the beginning of the COVID-19 pandemic to improve access to health technologies essential for response and mitigation. “Yet the pursuit of accelerating access, while safeguarding the safety, effectiveness and quality of the products, created tensions and pressures within national regulatory authorities,” Dr. Barbosa said.

In 2010, PAHO member countries adopted a resolution calling for strengthening regulatory systems, which was the first of its kind for the World Health Organization (WHO).  The resolution established regulatory systems as a public health priority and underscored the need to ensure that medical products comply with international standards and are affordable and accessible.

“The Region of the Americas has made great progress in strengthening national regulatory authorities over the past decade, but work must continue,” Dr. Barbosa said.  “Strengthening regulatory systems takes time and commitment, and requires national leadership for sustainability.”