American countries endorse policies to strengthen regulatory systems for medicines

Health ministers in the Region of the Americas yesterday endorsed a series of measures to strengthen regulatory systems in all Pan American Health Organization (PAHO) Member States to ensure that medicines and health technologies are safe, effective, and of high quality.

PAHO said in a statement that the measures were endorsed by PAHO’s 30th Pan American Sanitary Conference.

The recommendations to strengthen the governance and capacity of regulatory systems, improve regional integration, and promote convergence included were adopted.

“Regulatory systems are essential to ensure the availability of and promote equitable access to quality medicines and other health technologies, such as diagnostic tools and personal protective equipment,” said James Fitzgerald, director of health systems and services at PAHO.

He said it is important that “countries can create the ecosystems necessary for developing and producing medicines and health technologies, including current efforts to boost regional vaccine production in Latin America, which is critical to be prepared for a future pandemic.”

The recommendations contained therein are intended to help countries strengthen governance and oversight of regulatory systems and ensure that these systems are coherent, transparent, and based on best practices.

They also aim to improve regulatory harmonization and convergence and to implement the new assessment systems based on the World Health Organization’s (WHO) global comparative analysis tool.

PAHO recalled that “the Region has made great strides in building capacity and control systems, including the designation of eight regional national reference regulatory authorities (NRAs) with the necessary capacity to effectively monitor and control the approval of medicines.”

The continental body said that recent NRA reforms have also led to more transparent approval processes, with corresponding improvements in access to medicines and other technologies.

Fitzgerald said that despite this progress, significant challenges and asymmetries remain.

“In Latin America and the Caribbean, the allocation of financial and human resources to national regulators has remained relatively stable over the past five years, while the pharmaceutical market has continued to grow in terms of value, volume, and complexity of products,” he said.

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