The European regulatory system for approval of medicinal products is globally recognised
as a unique platform for regulatory work-sharing and mutual recognition. As such, it …

Regulatory science involves articulating knowledge that can establish the scientific bases for
the definition of adequate and efficient regulatory mechanisms and practices. The interfaces …

Introducción: Los defectos de calidad son incumplimientos de especificaciones de calidad
aprobadas en la autorización sanitaria para un medicamento de uso humano. Objetivo …

Introduction: Quality defects are breaches of quality specifications approved in the health
authorization of a medicinal product for human use. Objective: Describe the role of regional …

Background: International accreditations of drug regulatory authorities not only lead to
improvement in their functioning but pharmaceutical firms are also benefited. The aim of this …

A ciência regulatória é o campo de articulação de saberes que visa estabelecer as bases
científicas para a definição de mecanismos e práticas regulatórias adequadas e eficientes …