TRS 1033 - Annex 11: Good regulatory practices in the regulation of medical products
Annex 11, WHO Technical Report Series, No.1033, 2021
9 October 2021
| Technical document
Overview
A fundamental role of government is to protect and promote the health and safety of the public, including by delivering health care. A well-functioning health care system requires available, affordable medical products that are safe, effective and of assured quality. As medical products are essential in the prevention, diagnosis and treatment of disease, the consequences of substandard and falsified medical products can be life threatening. This is a concern, as users of medical products are not usually in a position to judge their quality. The interests and safety of the public must therefore be entrusted to a regulatory body or bodies that ensure that only products in legal trade are available and that marketed products are safe, perform as claimed and are of assured quality.
WHO Team
Access to Medicines and Health Products (MHP),
Health Product Policy and Standards (HPS),
Norms and Standards for Pharmaceuticals (NSP),
Technical Standards and Specifications (TSS)