Introduction

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:

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:

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 Chart.

• CDER Oranization Chart.

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.

• CDER Forum, October 6 - 10, 2008: Rockville, MD

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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:

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

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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.