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.

Provider administering medicine
Key facts

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
PAHO Response

PAHO has convened two conferences on drug regulatory harmonization in the Americas. These conferences have served as an open forum for representatives of the drug regulatory authorities, the pharmaceutical industry, consumer groups, academia, regional professional associations, and other interested groups from all regions of the Americas, which has facilitated communication and the exchange of information on this topic of common interest. As a result of these conferences, harmonization activities were recognized as important areas to be focused on to ensure that national authorities in the Region have access to state of the art information.