Effective medicines and health products regulation promotes and protects public health in several ways. It guarantees that medicines and health products are of the desired quality, safety and efficacy. It ensures they are manufactured, stored, distributed and dispensed properly. It enables the discovery and sanctioning of illegal manufacture and trade. And it ensures that health workers and patients have the information they need to use medicines and health products correctly.

A weak regulatory system can affect patient outcomes and may harm initiatives to improve access to medicines and health products. Weak regulations and enforcement of law in many countries leads to a rise in substandard and fake medical products in markets. 

WHO’s Access to Medicines and Health Technologies programme supports countries to:

strengthen the capacity of national regulatory authorities (NRAs) to assess and monitor the quality, safety and efficacy of medicines, vaccines, blood and other products of human origin, and health products;

strengthen the capacity of NRAs to detect substandard and fake medical products;

set up and run effective regulation and quality assurance systems to ensure the quality, safety and efficacy of medicines and health products;

establish regional networks for collaboration, knowledge exchange, capacity-building, sharing of work, and coherence of regulatory activities;

promote the concept of reliance, as needed, and facilitate collaborative decision-making at the regional level;

strengthen NRAs to reach maturity levels 3 and 4 and WHO-Listed Authority standards for medicines and vaccines regulation;

document best practices to improve access to medicines and health products and to establish regulatory mechanisms for essential medicines prone to shortages; and

strengthen post-market surveillance to detect, assess and prevent adverse effects and incidents for medicines and health products.