Harmonized requirements for the licensing of vaccines in the Americas and Guidelines for preparation of application
978 92 75 13083 4
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[Introduction]. Responsibility for the quality, safety and efficacy of vaccines lies first and foremost with the manufacturer. The National Regulatory Authorities (NRA) in each country must establish procedures to ensure that products and manufacturers meet the established regulatory criteria. Vaccines are products of biological origin which exhibit some intrinsic variability. They are characterized by complex manufacturing processes and are administered to large numbers of healthy children, adolescents and adults. Their quality can not be assessed solely by testing the final product alone. It is recommended that the NRAs establish a specific regulatory system for this type of product. A basic function of NRAs is to evaluate the quality, efficacy and safety of vaccines. This involves authorizing their use, distribution and sale, which implies granting a license and a market authorization. In order to license a vaccine, the NRAs must first set requirements for applicants to comply with. These requirements include the information needed in the application file, and evidence that the vaccine has passed the stages of research, development, production and quality control, as well as clinical testing, and guarantees that the quality, safety and efficacy required of the vaccine to be used in humans has been established. Another important aspect to consider in the vaccine evaluation process is that the manufacturing facilities must comply with good manufacturing practices (GMP). The NRA must have a legal authority and regulatory basis so that it can carry out its functions independently, transparently and with authority; therefore, its staff must be trained and have the experience needed to do the evaluation.
Requisitos armonizados para el registro de vacunas en la Región de las Américas y Guía para la preparación de una solicitud de registro sanitarioExigences harmonisées pour l’homologation des vaccins dans la Région des Amériques et Guide d’application
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