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CDER Report to the Nation: 2002

Table of Contents

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International Activities

Index

• Mission
• Highlights
• International Conference on Harmonization
• Harmonization initiative in the Americas
• U.S.-European Union Mutual Recognition Agreement
• Internet sources

Mission

We participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements and achieve appropriate reciprocal arrangements.

Highlights from 2002 include:

• Completing the electronic Common Technical Document.
• Publishing seven ICH documents.

International Conference on Harmonization

Harmonization-making the drug regulatory processes more efficient and uniform-is an issue that is important not only to Americans, but to drug regulatory agencies and pharmaceutical companies throughout the world. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use has worked to bring together government regulators and drug industry experts from innovator trade associations in the European Union, Japan and the United States.

We are leading the FDA's collaboration with the ICH. This work will help make new drugs available with minimum delays not only to American consumers but also to patients in other parts of the world.

The drug regulatory systems in all three regions share the same fundamental concerns for the safety, efficacy and quality of drug products. Before ICH, many time-consuming and expensive technical tests had to be repeated in all three regions. The ICH goal is to minimize unnecessary duplicate testing during the research and development of new drugs. The ICH process results in guidance documents that create consistency in the requirements for product registration.

Common Technical Document

The ICH Common Technical Document allows data in the same format to be submitted to drug review authorities in all three ICH regions.

Last year, we completed work on making the document suitable for electronic submission.

ICH guidance documents

Last year we published seven ICH guidance documents.

As of April 30, 2003, we had published 45 final documents and eight drafts.

Harmonization initiative in the Americas

We are working with the Pan American Health Organization to promote regulatory harmonization within the Americas. PAHO is part of the United Nations system, serving as the World Health Organization's regional office for the Americas. The initiative, called the Pan American Network for Drug Regulatory Harmonization or PANDRH, will search for common ground on various topics in a prioritized work plan.

We are the lead for two topics of high priority-good manufacturing practices and bioequivalence. We are working with the countries of Latin America to provide training on these two important issues. Training to the same standards should help lead to harmonization. Other urgent issues are good clinical practices and counterfeit drugs.

U.S.-European Union Mutual Recognition Agreement

This agreement would provide for reciprocal reliance on inspection systems in the United States and each of the 15 member nations of the European Union. The globalization of the pharmaceutical industry is outpacing our resources to inspect pharmaceutical manufacturing plants worldwide. Once fully implemented, the agreement would allow us to base our regulatory decisions on inspection data from "equivalent authorities" in the European Union. Equivalent authorities are those with regulatory systems for good manufacturing practices that we have assessed and determined will achieve a comparable level of public health protection.

While the agreement would allow us to use an inspection report from one of our European counterparts as though it were our own, the actual regulatory decision would be up to us. Our experts in good manufacturing practices are leading the FDA team that is working with a team from the European Union to implement this agreement.

A planned three-year transition to full implementation has ended, and two important issues remain to be resolved:

• The European Union says it will not proceed until we provide a complete schedule for assessment of all of the member state authorities.
• We want assurance of being able to exchange information with regulators as they are found equivalent, rather than waiting for all of them to be done as the European Union has wanted.

MRA update

• This past year we proposed a joint procedure providing for the exchange of inspection reports and provided an assessment of the progress made in exchanging certain product quality information. These issues were provided for review to the European Union.
• Our audit team prepared to visit the second member state after substantially completing the first, but the assessment was put on hold by the European Union.
• The European Union has not resumed their assessment of our system.

IInternet sources

• More information about our international activities, including Spanish language materials, is at http://www.fda.gov/cder/audiences/iact/iachome.htm.
• We have published ICH documents as guidances to industry. These are on our Web site at http://www.fda.gov/cder/guidance/index.htm.
• PAHO information is at http://www.paho.org. Information on PANDRH is at http://www.paho.org/english/gov/cd/cd42_13-e.pdf.
• The Mutual Recognition Agreement is at http://www.mac.doc.gov/mra/mra.htm.

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