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International Activities

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International Activities


The growth of world trade in FDA-regulated products, such as drugs, medical devices, and foods, calls for the Agency to focus on its role in the international community. To this end, the FDA's Office of International Programs (OIP) was created to coordinate the Agency's interactions with foreign countries and regulatory counterparts, set priorities for international activities, and provide overall policy guidance on international issues. To carry out these activities, the Office of International Programs is composed of four major groups:

  • 1) International Scientific Activities and Standards Staff
  • 2) International Relations Staff
  • 3) International Agreements Staff
  • 4) International Planning and Resource Management Staff

In carrying out their responsibilities, OIP staffs frequently work with scientific and technical experts from the Agency's various centers.

In a similar manner, CDER's International Activities Coordinating Committee (IACC), chaired by the Center Director, was established to lead the Center's participation in international initiatives and to coordinate and discuss these activities.  IACC's activities include:

  • Establishing and harmonizing international standards, regulations, and legislation
  • Regulatory and compliance surveillance including import monitoring and foreign inspections
  • Scientific collaboration
  • Technical assistance, training, and education
  • Hosting foreign visitors
  • Monitoring trade and export issues related to health and safety
  • Cooperating with foreign governments and international organizations
  • Communicating with other U.S. Federal agencies on international issues
  • Supporting FDA's international programs

For more information on the responsibilities of IACC, please see MAPP 4160.1. PDF document

CDER also participates in discussions of scientific and technical matters with regulatory counterparts throughout the world, as well as in activities sponsored by the World Health Organization and international trade organizations.  These activities follow the mandate of the Food and Drug Administration Modernization Act of 1997 to establish standard regulations worldwide for the products it regulates. Among negotiators, this effort is called "international harmonization."

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IACC Organization

Manual of Policies and Procedures (MAPPs) for International Activities

MAPPs are approved practices and procedures followed by CDER staff to help standardize the new drug review process and other activities.  All MAPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities, and procedures.

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CDER Forum for International Regulatory Authorities

The CDER Forum for International Regulatory Authorities provides information about the U.S. drug regulatory processes in an organized and integrated manner. It will explain the role of CDER as well as the science, technology, regulations and processes used to do our work.

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International Conference on Harmonisation (ICH)

ICH is the shortened name for The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.  ICH works to bring together government regulators and drug industry representatives from the U.S., the European Union, and Japan to make the international drug regulatory process more efficient and uniform.  This work will help make new drugs available with minimum delays to both American consumers and those in other countries.

The drug regulatory systems in all three regions share the same fundamental concerns for the safety, efficacy, and quality of drug products.   However, many time-consuming and expensive clinical trials have had to be repeated in all three regions.  An ICH goal is to minimize unnecessary duplicate testing during the research and development of new drugs.  Another goal is to develop guidance documents that create consistency in the requirements for new drug approval.

Some ICH projects include:

  • Medical Dictionary for Regulatory Activities (MedDRA) MedDRA is a new international medical terminology designed to improve the electronic transmission of regulatory information and data  worldwide.    It will be used to collect, present, and analyze information on medical products during clinical and scientific reviews and marketing.  It will be particularly critical in the electronic transmission of adverse event reporting and coding of clinical trial data. FDA is already using MedDRA in its Adverse Events Reporting Systems (AERS)

  • Common Technical Document (CTD). PDF document   This document will provide an international standard format for submitting safety and efficacy information about a new drug.

For a recent summary of FDA-ICH activities, see CDER Report to the Nation:  International Activities

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International Conference on Harmonisation Guidances

The ICH process results in guidance documents that create consistency in the requirements for new drug approval.  Guidance documents represent the Agency's current thinking on a particular subject. These documents provide guidance on the processing, content, evaluation, and approval of applications. They also establish policies intended to achieve consistency in the Agency's regulatory approach and establish inspection and enforcement procedures.  Because guidances are not regulations or laws, they are not enforceable, either through administrative actions or through the courts.  An alternative approach may be used if such an approach satisfies the requirements of the applicable statutes, regulations, or both.

ICH guidances are developed through a five-step process, 1) consensus building, 2) start of regulatory action, 3) regulatory consultation, 4) adoption of text, and 5) implementation.  For a full description of the process, please see The ICH Guidelines.  When a guidance document reaches Step 2 or Step 4 in the ICH process, FDA publishes a notice of availability in the Federal Register.  Guidances are posted on the Internet and placed in the Docket for viewing and public comment.   Notices for Step 2 guidances include a date for receipt of written comment.  Because Step 2 documents are drafts, they do not conform with the Agency's Good Guidance Practices (GGP) policy.  Step 4 guidances must be reformatted and edited to be consistent with the GGPs.  This is because the 1997 U. S. Food, Drug and Cosmetic Act required the Agency to make GGPs the law.  A proposed rule on GGPs was published in February 2000 and is in the process of being finalized.

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Spanish Language Materials

Disclaimer:  These documents have undergone review by our Spanish speaking reviewers but not editing. The English version of the document is considered the official guidance on the topic.  All CDER guidances can be found at http://www.fda.gov/cder/guidance/index.htm


Good Manufacturing Practice

CDER Handbook Spanish Edition PDF Doc  (4/2/2001)

Regulatory Authority

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International Partners

  • Globalhealth.gov.  This site addresses global health, and more importantly, the link between domestic and international health issues.  
  • World Health Organization (WHO).  WHO's Essential Drugs and Medicines Policy provides global guidance on essential drugs and medicines, and addresses the implementation of national drug policies that ensure equal access to essential drugs, and drug quality and safety. 
  • International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use.  ICH was established in 1990 to bring together the regulatory authorities of the European Union, Japan, and the U.S., plus experts from pharmaceutical industries to produce common regulatory activities for the approval of new drug products.  Its purpose is to eliminate unnecessary and unreasonable delay in the global development and availability of safe and effective new drugs.  
  • European Federation of Pharmaceutical Industries and Associations (EFPIA). The EFPIA  represents the pharmaceutical industry in Europe. Its members account for approximately 98% of the pharmaceutical industry's production in the European Union.
  • The European Agency for the Evaluation of Medicinal Products (EMEA).  EMEA's mission is to contribute to the protection and promotion of public and animal health by providing high quality evaluation of medicinal products. Its goal is to develop a single European marketing authorization controlling the safety of medicines for humans and animals.
  • The International Federation of Pharmaceutical Manufacturers Associations (IFPMA).  IFPMA represents the worldwide research-based pharmaceutical industry and facilitates the development of position statements on policy issues.  It serves as a bridge between industry, the World Health Organization, and other international health agencies.  It also serves at the ICH secretariat.
  • Ministry of Health, Labour and Welfare.  Japan's national regulatory agency.
  • Pan American Health Organization (PAHO).  PAHO sponsored a series of conferences on Drug Regulatory Harmonization related to pharmaceutical regulatory harmonization in the Americas.   These conferences included regulators and representatives from industry, consumer groups, and professional organizations.  This web page contains links to summaries from these conferences.
  • Organization for Economic Cooperation and Development (OECD).  The OECD is a 29 member international group that discusses and develops economic and social policy in such areas as trade, public management, development assistance, and financial markets.
  • Trans-Atlantic Consumer Dialogue.  This is a forum of U.S. and European Union (EU) consumer organizations that jointly develops policy recommendations to promote the consumer interest in EU and U.S. policy making.
  • Trans-Atlantic Business DialogueThe aim of the TABD is to boost transatlantic trade and investment opportunities among the U.S. and the European Union (EU) by removing excessive regulation, duplication, and differences in the EU and U.S. regulatory systems and procedures.

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Topics of Special Interest to the International Community

  • Information for Clinical Investigators.  This web page includes guidances, information on Institutional Review Boards (IRBs), and protection of human subjects in clinical trials, along with links to clinical regulatory and compliance resources.
  • Drug Application Regulatory Compliance.  This web page offers guidance documents, compliance policy programs and guidelines, and frequently asked questions about compliance activities.
  • Post Drug-Approval Activities.  This web page provides descriptions of FDA's postmarketing programs, plus the regulations, policies, and procedures for postmarketing surveillance programs.

How to Contact Us

We ask you to take time to communicate with CDER about this web site.  What information is and isn't useful to you in understanding CDER's international activities?  What additional items or categories of information would you like us to add?  Please use our comments form.

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FDA/Center for Drug Evaluation and Research
Last Updated: May 12, 2008
Originator: OTCOM/DLIS