Within the framework of implementation of pharmaceutical regulation and in order to ensure that medicines fulfill the quality standards established at the global level, improving the availability of effective, safe, and quality medicines, the Pan American Health Organization (PAHO) is conducting technical cooperation projects in accordance with the mandates received from its governing bodies and based on the guidelines of the World Health Organization.

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 regulations are applicable to all phases of the production process, including the different stages of manufacture, packaging, transportation, distribution, reception, and storage or import of the product, in order to guarantee the quality of the product until the time of its use.

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

For the institution to be effective it should have:

• A legal base for all of its normative and regulatory roles
• Sufficient human and financial resources
• Access to appropriate scientific knowledge and access to a quality control laboratory

As part of the regulatory authority, the instrument empowered to perform the quality control tests is the national laboratory for control of medicines, also referred to in some countries as the center for control of medicines or the institute for control of medicines.

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.