Regulating Medicines in a Globalized World

This book PDF is perfect for those who love Medical genre, written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press which was released on 25 April 2020 with total hardcover pages 169. You could read this book directly on your devices with pdf, epub and kindle format, check detail and related Regulating Medicines in a Globalized World books below.

Regulating Medicines in a Globalized World
Author : National Academies of Sciences, Engineering, and Medicine
File Size : 47,6 Mb
Publisher : National Academies Press
Language : English
Release Date : 25 April 2020
ISBN : 9780309498630
Pages : 169 pages
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Regulating Medicines in a Globalized World by National Academies of Sciences, Engineering, and Medicine Book PDF Summary

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

Regulating Medicines in a Globalized World

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials

Get Book
International Regulatory Harmonization Amid Globalization of Drug Development

The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been

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