Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications.

Argotti, Urimara; Leyens, Lada; Lisbona, Carlos; López, Pilar; Alonso-Orgaz, Sergio; Nevado, Angel; Cozzi, Virginia

Argotti, Urimara; Leyens, Lada; Lisbona, Carlos; López, Pilar; Alonso-Orgaz, Sergio; Nevado, Angel; Cozzi, Virginia.

Afiliación

Argotti U; International Regulatory Policy Department, Latin America Productos Roche, S.A. de C.V., Mexico City, Mexico.
Leyens L; Product Development Regulatory, F. Hoffmann-La Roche AG, Basel, Switzerland.
Lisbona C; Medical Writing Department, LIDESEC S.L, Madrid, Spain.
López P; Medical Writing Department, LIDESEC S.L, Madrid, Spain.
Alonso-Orgaz S; Medical Writing Department, LIDESEC S.L, Madrid, Spain.
Nevado A; Medical Writing Department, LIDESEC S.L, Madrid, Spain.
Cozzi V; Medical Affairs Department, Roche Central America, Venezuela, and the Caribbean, Heredia, Costa Rica. virginia.cozzi@roche.com.

Ther Innov Regul Sci ; 57(6): 1287-1297, 2023 11.

Article en En | MEDLINE | ID: mdl-37682461

Asunto(s)

COVID-19; Aprobación de Drogas; Humanos; Preparaciones Farmacéuticas; América Latina; Pandemias

Palabras clave

Expedited regulatory pathways; Innovative clinical trial designs; Latin America regulations; Marketing authorization procedures; New clinical evidence approach; Reliance pathways

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Aprobación de Drogas / COVID-19 Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Ther Innov Regul Sci Año: 2023 Tipo del documento: Article País de afiliación: México Pais de publicación: Suiza

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