The document discusses the policy to strengthen national regulatory systems for medicines and other health technologies. It emphasizes that equitable access to safe, effective, and quality medicines and health technologies is crucial for achieving universal health. The regulatory system plays a pivotal role in overseeing medical products to ensure they meet safety, efficacy, and quality standards. The document recalls that in 2010, the Region of the Americas adopted a system for evaluating and qualifying regulatory systems. The objective of this policy is to renew mandates in light of the achievements and challenges faced by the Region in regulating medical products.
The document highlights the progress made in regulatory convergence and harmonization, with the creation of new National Regulatory Authorities (NRAs) and the strengthening of existing ones. However, challenges persist, with significant disparities in the Region. Some NRAs have yet to adopt continuous improvement plans, and there are gaps in post-marketing surveillance. The document also touches upon the risks posed by substandard and falsified medical products, the importance of over-the-counter sales regulations, and the role of regulatory systems during public health emergencies, such as the COVID-19 pandemic.
The document concludes by emphasizing the need for a unified tool and methodology to evaluate all regulatory systems, identify gaps, and strengthen them. The Region of the Americas has been actively involved in shaping this global strategy.
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