Collaboration, Not Competition: Developing New Reliance Models - Regulatory Collaboration. Exchange of Assessment Reports (ARs) with Regulators Outside the European Union (EU). (WHO Drug Information Vol. 30, No. 4, 2016)
(2017; 9 pages)

Abstract

At a time when modern medicines manufacture and distribution are increasingly globalized, cooperation between medicine regulators has become essential, and multiple models of regulatory collaboration are being implemented in all regions of the world. The European regulatory system for medicines is unique in the global regulatory environment and may serve as a model for other countries or regions for building trust and mutual reliance. The EU Medicines Agencies Network Strategy to 2020 highlights the strong international role that the EU network can play in promoting reliance and work-sharing with other regulators.

This paper provides a discussion of the programmes and initiatives in which medicines regulators rely on collaboration and on assessment work carried out by other regulators while retaining responsibility for their own regulatory decisions. It also proposes some tools and suggestions to make these approaches more systematic. The paper concentrates on assessment of applications for marketing authorization, but many concepts expressed here can be applied to other regulatory areas such as inspections and pharmacovigilance.

Although the focus is on exchange of documents produced by the European Medicines Agency (EMA) and other agencies in the EU network with regulators outside the EU, it is recognized that the EU regulatory system also has much to gain by exchanging experience with, and receiving information from, regulators in other regions of the world.

 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 1, 2019