Regulatory processes resources
The following reports and websites provide details about regulatory processes for global health technologies. Resources are listed alphabetically within each subcategory.
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United States
FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad -- sharing news, background, announcements, and other information about the work done at the FDA on behalf of the American public.
Launch date: December 2011
The FDA's role in global health (194 KB PDF)
This fact sheet from the Global Health Technologies Coalition examines how the FDA plays a critical role in ensuring the safety of health tools to prevent, diagnose and treat dangerous diseases that affect millions of people worldwide.
Author: Global Health Technologies Coalition
Publication date: November 2011
This book examines the outcomes of a public workshop held by the Institute of Medicine (IOM) to examine the state of regulatory science and to explore ways to enhance regulatory science.
Authors: Board on Health Sciences Policy and the IOM
Publication date: February 2011
S. 3697 Priority review voucher (PRV) legislation (603.25 KB PDF)
Legislation to amend the Federal Food, Drug, and Cosmetic Act to improve the priority review voucher incentive program relating to tropical and rare pediatric diseases.
Guidance from the US Food and Drug Administration to assist sponsors in developing vaccines targeted against infectious diseases or conditions endemic in areas outside of the United States.
Authors: US Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research
Publication date: September 2008
Guidance for industry: Tropical disease priority review vouchers (61 KB PDF)
Guidance from the US Food and Drug Administration on tropical disease priority review vouchers, designed to encourage development of new drug and biological products for prevention and treatment of certain tropical diseases.
Authors: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
Publication date: October 2008
US Food and Drug Administration (website)
The website of the agency charged with assuring the safety, efficacy, and security of health products and the food supply in the United States.
Global regulatory bodies
Text of the European Medicines Agency’s Article 58, a mechanism that allows the agency to give a scientific opinion for the evaluation of vaccines and drugs for human use intended exclusively for markets outside the European Union.
Registering New Drugs: The African Context (3,768 KB PDF)
This report from the George Institute for International Health and Drugs for Neglected Disease initiative issues new recommendations to strengthen regulatory authorization processes in Africa for drugs against neglected diseases.
Publication date: January 2010
World Health Organization: African Vaccine Regulatory Forum (AVAREF) (website)
This page of the World Health Organization’s website outlines the work of AVAREF, which supports regulatory systems for evaluation of vaccines in countries with few resources for regulation.
World Health Organization: EMEA Article 58 (website)
This page of the World Health Organization’s website provides scientific opinions on European pharmaceutical legislation called Article 58 that affects the regulation of medicinal products used only outside of the European Union.
