Regulation of Drug Prescribing Information in Latin America and the Caribbean.

OBJECTIVE: To describe the status of drug regulations in Latin America and the Caribbean, in force as of May 2021, and assess through a comparative exercise the differences between the countries under scope on prescribing information of drugs for human use. MATERIALS AND METHODS: A narrative review allowed the identification of the regulations concerning the prescribing information of drugs in 25 countries in Latin America and the Caribbean for the registration of prescription medications. On this basis, terms and concepts regarding this topic, the general provisions by the regulatory authorities for these products, applications for health registration and further amendments were identified for each country. RESULTS: The Latin American and the Caribbean countries included, manage and regulate drug prescribing information differently in terms of concepts, information publishing, structure for product information, among other criteria. Few health authorities publish product information on their website. Additionally, the patient information leaflet is not requested for prescription drugs in most of the studied countries. There is no standardized structure for drug product information within the region. CONCLUSIONS: A poor level of harmonization among the regulations from these countries regarding the content and management (e.g. if physical package insert is required or not, if it is subject to notification or approval) of the prescribing information of human use drugs became evident. Also, there is a visible lack of standardization of concepts for referring to a specific document (e.g., package insert for healthcare professionals, patient information leaflet and technical information for the drug product) and in the content itself.

Registro sanitario de medicamentos biológicos y biotecnológicos en América Latina / Marketing authorization of biologic and biotechnological products in Latin America

INTRODUCCIÓN: los medicamentos biológicos se definen como productos cuyos ingredientes activos son producidos por una fuente biológica, mientras que un producto biotecnológico se desarrollar a partir del aislamiento de un gen de interés y su clonación. MÉTODO: se realizó un estudio comparativo de las regulaciones vigentes a julio de 2020 relacionadas con medicamentos biológicos y biotecnológicos de los países de Centroamérica y el Caribe que actualmente disponen de un marco regulatorio para su registro, con respecto a aquellas de Chile y Brasil. RESULTADOS: existen diferencias relevantes en diversos aspectos. Dentro de la información general solicitada se encontraron variaciones para las definiciones de Autoridad Reguladora Estricta, producto biotecnológico, producto de referencia y producto innovador. También se hallaron divergencias para la información no clínica y clínica solicitada, y los programas de Farmacovigilancia. Para productos biosimilares se distinguieron particularidades referentes a su definición y la de ejercicio de biosimilitud, así como para aspectos propios de su utilización como lo son la extrapolación de indicaciones y la sustitución automática o intercambiabilidad. Finalmente, para su etiquetado se requiere mayor estudio por parte de las autoridades sanitarias. CONCLUSIONES: una vez realizada la revisión de la normativa respecto al registro sanitario de productos biológicos y biotecnológicos en nueve países de América Latina, se encontró que la información solicitada no se halla homologada

INTRODUCTION: biological products are defined as products whose active ingredients are produced by a biological source, while biotechnological medicine is developed from the isolation of a gene of interest and its cloning. METHOD: a comparative study was carried out of the regulations in force as of July 2020 related to biological and bio-technological drugs of the countries of Central America and the Caribbean that currently have a regulatory framework for their registration, with respect to those of Chile and Brazil. RESULTS: there are relevant differences in various aspects. Within the general information requested, variations were found for the definitions of Stringent Regulatory Authority, biotechnological product, reference product, and innovative product. Also, divergences were found for the non-clinical and clinical information requested and the Pharmacovigilance programs. For biosimilar products, particularities were distinguished regarding their definition and the exercise of biosimilarity, as well as for aspects of their use, such as the extrapolation of indications and automatic substitution or interchangeability. Finally, their labeling requires further study by the health regulatory authorities. CONCLUSIONS: after reviewing the regulations for the marketing authorization of biological and biotechnological products in nine Latin American countries, it was found that the requested information is not homologated