Unregistered, substandard, and falsified (SF) medical products threaten public health. Their presence in the market and high probability of consumption by the population can cause treatment failure, adverse reactions, and increase morbidity and mortality of patients. Moreover, these products increase the costs of medical care for the population and health systems.
Key facts
- Now, the prevalence of SF medical products is not clear. This problem affects all the countries in the world and all the medical products, from medicines to medical devices.
- In The Americas region, the National Regulatory Authorities (NRA) are responsible for the post-market surveillance actions. Among them is developing strategies for the prevention, detection, and response to the distribution of medical products SF.
- The problem also includes medical products unregistered or non-authorized for commercialization, and those reported as stolen, since there is an important level of uncertainty about their efficacy, quality, and safety.
PAHO Response
- It provides technical support to those responsible for post-market surveillance and market control programs to prevent, detect, and respond to SF product incidents.
- It encourages work through regional and global networks for the exchange of knowledge and best practices.
- Promotes training to develop and strengthen the capacities of National Regulatory Authorities.
