A government, through the regulatory authority for medicines, which can be constituted as a regulatory agency or a regulatory body for medicines, establishes and maintains the rules, laws, and policies required to ensure that medicines (including pharmaceutical products, vaccines, and other biologicals) are safe and effective, and fulfill the quality specifications offered by the producer.
The main functions of the regulatory authority for medicines are:
- Registration (licensing) of products
- Inspection and licensing for manufacturers
- Inspection and licensing for distributors
- Post-marketing surveillance
- Regulation of statements that can be made for commercial promotion of the products
- Authorization of clinical trials
This section provides information on the technical cooperation activities conducted by PAHO in conjunction with the national regulatory authorities and the national control laboratories in the areas of regulation and control of medicines, including pharmaceutical products, vaccines, and other biologicals.