CSP30/11 - Policy to Strengthen National Regulatory Systems for Medicines and Other Health Technologies

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Equitable access to safe, effective, and quality medicines and other health technologies is a prerequisite for achieving universal health. The regulatory system is an essential component of the health system and is responsible for the regulation and oversight of medical products to ensure they meet safety, efficacy, and quality standards to further equitable access and contribute to economic and social development.

Strengthening regulatory systems remains a public health priority for the Member States. In 2010, the Region of the Americas adopted a system for evaluating and qualifying regulatory systems and systems for recognizing national regulatory authorities (NRAs) of regional reference.

The objective of this policy is to renew the mandates, considering the achievements and new challenges confronting the Region in the regulation of all medical products of interest to the health system, as well as the potential role of regulatory systems in promoting the production of health technologies and responding to health emergencies.