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About CDER - Report |
U.S. Food and Drug Administration • Center for Drug Evaluation and Research |
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About CDER - Report |
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CDER Report to the Nation: 1999 International ActivitiesMissionWe participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements and achieve appropriate reciprocal arrangements. International Conference on HarmonizationHarmonization-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 (ICH) 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. However, many time-consuming and expensive technical tests have 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. The ICH model applies the most advanced scientific knowledge and coincides with our top priority of using state-of-the art science as the basis for efficient and rigorous drug reviews. Standard terminologyThe ICH Medical Dictionary for Regulatory Activities supports the classification, retrieval, presentation and communication of medical information throughout a drug's life cycle. It will be particularly important in the electronic transmission of adverse event reporting, both in the pre- and postmarketing areas, as well as in the coding of clinical trial data. We expect MedDRA to become the accepted standard for all regulatory activities. The terminology serves a vital public health need: to facilitate the collection, presentation and analysis of regulatory information on medical products during clinical and scientific reviews and marketing. Common Technical DocumentAn important goal of harmonization is to define a standardized format for submitting information about a new drug. Our objective is to reach agreement on an information package of technical data, in the same format and with the same content, that would be submitted to drug review authorities in all three ICH regions. The project is well on target with a final document expected in November 2000. Work on making the Common Technical Document suitable for electronic submission will take about six months longer. Second phase launchedThe ICH has embarked on a second phase of activities and agreed to broaden representation to other parties. The second phase of harmonization will have implications for already marketed drugs, over-the-counter drugs and generic equivalents. To keep pace with scientific advances, several guidances are being revised or considered for revision. Four areas of focusThe ICH areas of harmonization are efficacy, safety, quality and regulatory communications. These terms are used somewhat differently than similar American terms.
The 5-step ICH process1. An expert working group develops a draft guidance. 2. We obtain comments from citizens, industry, academia and others. 3. The regulatory members of the expert working group revise the draft based on comments received and pass it on to the ICH steering committee. 4. The steering committee approves the guidance and hands it over to the regional regulatory authorities. 5. The regulatory authorities implement the guidance in their regions according to their own national procedures. In this country, we follow good guidance practices, publish the guidances in the Federal Register and post them on our Web site. U.S.-European Union Mutual Recognition AgreementThis agreement provides for reciprocal reliance on inspection systems in the United States and 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 will allow us to base our regulatory decisions on inspection data from "equivalent authorities" in the European Union. Equivalent authorities are those have regulatory systems for good manufacturing practices that we assess and determine will achieve a comparable level of public health protection. While the agreement will allow us to use an inspection report from one or our European counterparts as though it were our own, the actual regulatory decision will be up to us. Last year marked the first year of a three-year transition period to implementation. Our experts in good manufacturing practices are leading the FDA team working with a team from the European Union to implement this agreement. We held a public meeting in December to advise our stakeholders about progress on the agreement. Internet sourcesWe publish the ICH documents as guidances to industry. These can be found on our Internet site at: http://www.fda.gov/cder/guidance/index.htm. More information about ICH activities can be found on the World Wide Web at: http://www.ifpma.org/ich1.html. The Mutual Recognition Agreement can be found on FDA's Website and at the European Union's Website at http://dg3.eudra.org/. Information about the most recent public meeting can be found at http://www.fda.gov/oia/homepage.htm. Mansfield fellowshipsTwo of our scientists have received two-year fellowships from The Mansfield Center for Pacific Affairs. The fellowships involve one year of Japanese language and area studies training and a second year in Japan working with drug regulators in the Japanese government.
FDA/Center for Drug Evaluation and Research |
