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 drug approval process infographic (website)

This infographic shows the approval process for drugs at the US Food and Drug Administration.

FDAVoice (website)

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

Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary (website)

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 for industry: General principles for the development of vaccines to protect against global infectious diseases (71 KB PDF)

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

Global Health Regulatory Requirements Database

The Global Health Regulatory Requirements Database is unique resource designed to help researchers and regulatory affairs professionals access the information they need to develop effective strategies for gaining approval to conduct clinical trials and market products. The database includes high-level regulatory information on a variety of countries in Africa, Asia, and Latin America, as well as links to key guidance documents and other resources where users can find more detailed information.

The African Vaccine Regulatory Forum

This is an introductory guide for product developers on the African Vaccine Regulatory Forum (AVAREF), which was founded in 2006 by the World Health Organization to support national regulatory authorities in making informed decisions concerning authorization of clinical trials, evaluation of product registration dossiers, and any other challenging issues related to vaccine evaluation.

Strengthening national regulatory capacity

This fact sheet by PATH describes how global investments to strengthen regulatory capacity in developing countries help ensure that desperately needed medical products are delivered, which improve health and equip countries with the expertise and infrastructure to make important health decisions for years to come.

Navigating WHO Product Decision-making: Medicines

This navigation guide is designed to help orient product developers to the players and processes involved in product-related decision-making relating to medicines at the World Health Organization. The graphic on page 2 serves as a starting point. Mouse over an individual entity to see a brief description and highlight the connections between that process or group and others on the graphic. Then click the “MORE” link inside the bubble for more detailed information on why specific groups and processes are important, how they operate, how they interact with one another, and where to look for more information.

Navigating WHO Product Decision-making: Pesticides

This navigation guide is designed to help orient product developers to the players and processes involved in product-related decision-making relating to pesticides at the World Health Organization. The graphic on page 2 serves as a starting point. Mouse over an individual entity to see a brief description and highlight the connections between that process or group and others on the graphic. Then click the “MORE” link inside the bubble for more detailed information on why specific groups and processes are important, how they operate, how they interact with one another, and where to look for more information.

Navigating WHO Product Decision-making: Vaccines

This navigation guide is designed to help orient product developers to the players and processes involved in product-related decision-making relating to vaccines at the World Health Organization. The graphic on page 2 serves as a starting point. Mouse over an individual entity to see a brief description and highlight the connections between that process or group and others on the graphic. Then click the “MORE” link inside the bubble for more detailed information on why specific groups and processes are important, how they operate, how they interact with one another, and where to look for more information.

Guideline on procedural aspects regarding a CHMP scientific opinion in the context of cooperation with the World Health Organization (WHO) for the evaluation of medicinal products intended exclusively for markets outside the community (187 KB PDF)

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.

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