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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, and 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.  |
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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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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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:
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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).
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Common Technical Document (CTD). This
document will provide an international standard format for submitting safety and efficacy
information about a new drug. A July, 2000 Press Release describes the progress on the CTD.
For a recent summary of FDA-ICH activities, see CDER Report to the Nation:
International Activities
FDA announces a public meeting entitles
"Preparation for Meetings in Brussels, Belgium Including Progress
on Implementation the the Common Technical Document," Notice
of Public Meeting
held January 17, 2002.
FDA announces a public meeting entitled ``Preparation for ICH Meetings in
Tokyo, Japan, Including Progress on the Common Technical Document and Possibilities for
New Topics." Optional
format: PDF. Meeting on May 8, 2001. (Posted 4/24/01).
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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 Process
for Harmonisation of 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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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
Bioavailability/Bioequivalence
- Guía para la Industria:
Procedimentos Estadisticos para Estudios de Bioequivancia Usando un Diseno Estandar
Cruzado de Dos Tratamientos (Posted 4/01)
- Guía para la Industria: Pruebas de disolución de formas de
dosificación oral sólidas de liberación inmediata. English version: Dissolution Testing of Immediate
Release
- Guía para la Industria: Formas de dosificación oral de
liberación prolongada: elaboración, evaluación y aplicación de correlaciones in
vitro/in vivo. English version: Extended Release Oral Dosage Forms:
Development, Evaluation, and Application of In Vitro/In Vivo Correlations.
(Issued 9/97)
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Exención de
los estudios de biodisponibilidad y bioequivalencia
in vivo para formas posológicas orales sólidas de liberación inmediata en base a un sistema de
clasificación de biofarmacéuticas.
(Issued 8/2000, Posted 8/24/2001). English version: Waiver
of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release
Solid Oral Dosage Forms Based on a Biopharmaceutics Classification
System.
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Formas
posológicas orales sólidas de liberación inmediata Cambios
de escala y posteriores a la aprobación: documentación
química, de fabricación y controles, de pruebas de disolución in vitro y bioequivalencia in vivo.
(Issued 11/1995, Posted 8/24/2001).
English version: SUPAC-IR: Immediate-Release Solid Oral Dosage
Forms: Scale-Up and Post-Approval
Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution
Testing, and In Vivo Bioequivalence.
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SUPAC-MR:
Formas posológicas orales sólidas de liberación modificada Cambios en escala y posteriores a la
aprobación: química, fabricación y
controles; pruebas de disolución in vitro y documentación de bioequivalencia in
vivo.
(Issued 9/1997, Posted 8/24/2001).
English
version: SUPAC-MR: Modified
Release Solid Oral Dosage Forms Scale-Up and Postapproval
Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution
Testing and In Vivo Bioequivalence Documentation.
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Estudios de
biodisponibilidad y bioequivalencia para productos
parmacéuticos administrados oralmente - consideraciones generales.
(Issued 10/2000, Posted 8/24/2001). English version:
Bioavailability
and Bioequivalence Studies for Orally Administered Drug Products -
General Considerations.
Good Manufacturing Practice
CDER Handbook Spanish
Edition
(4/2/2001)
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- Exchange of Letters Between
the Food and Drug Administration and Japan Concerning the Exchange of Certain Information
on Pharmaceutical Products - Notice, Federal Register, April 24, 2001. Optional
format: PDF.
(Posted 4/24/01).
- Cooperative Arrangement Between the Food
and Drug Administration of the Department of Health and Human Services of the United
States of America and the Therapeutic Goods Adminstration of the Department of Health and
Aged Care of the Commonwealth of Australia Regarding the Exchange of Information on
Current Good Manufacturing Practice Inspections of Human Pharmaceutical Facilities.
(Issued 10/11/00, posted 10/17/00).
- Disclosure of Information to
Foreign Regulators - Final Rule, Federal Register, March 7, 2000.
Public Information; Communications with State and Foreign Government
Officials. The rule states that FDA may disclose confidential commercial
information to international organizations only with the consent of the person who
submitted the information to FDA.
- Federal
Register: April 10, 1998 (Volume 63, Number 69). Mutual Recognition of the Food and Drug Administration and European
Community Member State Conformity Assessment Procedures; Pharmaceutical GMP Inspection
Reports, Medical Device Quality System Evaluation Reports, and Certain Medical Device
Premarket Evaluation Reports.
- U.S. - European Union - Mutual Recognition
Agreement: Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs).
Joint Procedure for the Exchange of Serious or Life-Threatening Human/Animal
Pharmaceutical Product Recalls. (Issued 3/23/00, Posted 3/30/00). This agreement describes the procedures members countries observe to alert
each other to product recalls involving drugs, biologics, and veterinary products.
- U.S.- European Union - Mutual Recognition
Agreement on Pharmaceutical Good Manufacturing Practices. After a
three-year implementation period, this agreement enables FDA to rely on our counterparts
in the European Union to inspect facilities in their countries that
manufacture drugs for the United States market. For more information, please see
"A Plan That Establishes a
Framework For Achieving Mutual Recognition of Good Manufacturing Practices Inspections."
- International
Memoranda of Understanding (MOU). This 1995 guidance describes how the Agency
initiates, develops, and monitors MOU's with foreign government agencies. MOU's promote
harmonization of laws, regulations, and enforcement activities that enhance FDA's ability
to carry out its mission.
- For more information on international agreements, please see Foreign Language and International Information.
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- 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. For more information on ICH, see
"ICH Sets Its
Scene for the 21st Century"
and "The Value and Benefit of ICH to
Industry."
- 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 Dialogue.
The 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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- 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.
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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: April 4, 2002
Originator: OTCOM/DLIS
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