This section provides information on the technical support activities and procedures established by the Pan American Health Organization (PAHO) with regard to procurement of the biologicals/biotechnology products to be used in the health programs of the PAHO member countries. The vaccine procurement activities conducted through the Revolving Fund are not included in this section.

The quality of biologicals and medicines in general is the main responsibility of the manufacturer. Nevertheless, there must be health surveillance systems that can be used to monitor the quality, safety, and efficacy of the products sold. This is conducted by the national regulatory authority (NRA). As a result, the product procurement process performed through the PAHO Strategic Fund is based mainly on:

• Reference standards established by the World Health Organization (WHO) for biologicals/biotechnology products.
• Definition of the technical specifications and procurement requirements.
• Technical assessment of compliance with the established requirements.
• Monitoring of product quality and safety through the health surveillance conducted by the NRAs.
• Technical recommendation to the countries on the use of specific products.