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CDER Report to the Nation: 2004 Print version
3 International ActivitiesIndex
President’s Emergency Plan for AIDS ReliefThe president’s $15 billion plan for AIDS relief around the world was announced in 2003 and has a special focus on 15 countries hardest hit by the HIV epidemic. It targets three specific areas related to HIV/AIDS:
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Prevention of HIV transmission. In May 2004, we announced we would implement a new, expedited review process to ensure that the United States could provide safe, effective drugs to developing countries. That same month, we published a draft guidance encouraging manufacturers to submit applications for fixed-dose combination and co-packaged versions of previously approved antiretroviral therapies. In June 2004, we traveled to South Africa and India to discuss the new guidance with generic drug manufacturers. Through our commitment to expedited review, we hope to make safe, effective and affordable quality drugs available quickly for patients with HIV or AIDS in the undeveloped world. Tentative approval—whether for a new drug application or a generic drug application—will be the regulatory mechanism by which low-cost versions of innovator drugs sold in the developed world will become eligible for purchase under the emergency plan. Our tentative approval (click here for more) means that existing patents or exclusivity prevent the product from being sold in the United States. We are committed to ensuring that only quality drug products reach the affected nations as quickly as possible. Because we lack information about most clinical laboratories and manufacturing sites associated with the products seeking approval under the emergency plan, our involvement also includes:
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Outreach activities. 3-drug regimen eligible for purchase under president’s planIn January 2005, within two weeks of receiving a complete application, we tentatively approved a complete three-drug product. It consisted of consisted of co-packaged lamivudine/zidovudine fixed-dose combination tablets and nevirapine tablets. Generic drugs eligible for purchase under president’s planAs of July 22, 2005, we had tentatively approved these generic drugs:
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 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 is making 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 in the three regions. Common Technical DocumentThe ICH Common Technical Document allows data in the same format to be submitted to drug review authorities in all three ICH regions. Specifications for electronic submission of the CTD, known as the eCTD, were completed in 2002. Electronic Common Technical DocumentElectronic submissions using the eCTD can be used to submit all applications and related submissions (click here for more) such as promotional materials and adverse events. Among other things, the eCTD allows reviewers to: n Create an up-to-date, cumulative table of contents for the entire application at any time. n Access any electronic submission from a single screen. n Download files so submissions can be used even when the reviewer is off the network. Harmonization guidancesWe publish International Conference on Harmonization documents as guidances to industry on our Web site at http://www.fda.gov/cder/guidance/index.htm. As of June 8, 2005, we had: 49 final guidances
8 draft guidances
Information-Sharing AgreementsBecause of enhanced cooperation among regulators around the world, FDA has entered new international agreements in which we play a critical implementation role. We have a growing list of regulatory partners worldwide with whom we can pursue more open dialogue on emerging issues as well as exchange routine information on scientific review, policy development and enforcement. Japan and AustraliaWe routinely exchange recall information about products of interest to Japan and Australia and communicate emerging enforcement activities of mutual interest. We continue to collaborate with our counterparts regarding site inspection information. With limited inspection resources of our own, we increasingly depend on foreign regulatory inspections and incorporate their inspection findings into a risk-based program for future inspection. European Agency for the Evaluation of MedicinalsThis agreement establishes a basis for exchanging confidential information with the European agency primarily responsible for approving drugs. It permits our review and compliance staff to share important information about pending approvals, post-marketing surveillance and enforcement actions concerning products and facilities under the European agency’s oversight. Implementation, to be phased in, includes activities to build understanding and mutual confidence in one another’s systems. Mexico and CanadaFDA is working jointly with our North American neighbors to develop information exchange arrangements about drug manufacturing facilities in each of our countries and to share information about product recalls that may impact our consumers. Our recent contributions to this long-standing effort have been vital in moving this relationship in mutually beneficial direction. An agreement with Canada provides for the exchange of information about pending approvals, post-marketing surveillance and enforcement actions. Exchanges of emerging compliance issues and site-specific information have already begun. SwitzerlandThe working arrangement with Switzerland began several years ago and important progress has been made in the past year. The present agreement addresses the need for protection of confidential information and provides for the exchange of information about marketing approval decisions, post-market surveillance, policy developments and compliance or enforcement activities of mutual interest. Progress in implementing this arrangement includes the exchange of technical staff and training opportunities. Successful joint inspections have helped foster mutual confidence and improve communications. Pharmaceutical Inspection Cooperation SchemeAs part or our initiative to improve manufacturing practices (click here for more), FDA announced it would seek membership in the Pharmaceutical Inspection Cooperation Scheme. This is an international organization dedicated to drug regulatory harmonization and collaboration in the area of good manufacturing practices. Membership would formalize a working relationship that has been in effect for many years and that will offer greater opportunities for expanding international cooperation in drug quality regulation. Export Certificates
We promote goodwill and cooperation between the United States and foreign governments through the Export Certificate Program. These certificates enable American manufacturers to export their products to foreign customers and foreign governments. The demand for certificates by foreign governments remains high due to expanding world trade, ongoing international harmonization initiatives and international development agreements. The certificates attest that the drug products are subject to inspection by the FDA and are manufactured in compliance with current good manufacturing practices. Export certificates verify that drug products being exported: n Were freely marketed in the United States. n Were in compliance with U.S. laws and regulations. n Met certain national or international standards, such as quality standards. n Were free of specific contaminants. Internet resourcesMore information about our international activities, including Spanish language materials, is at http://www.fda.gov/cder/audiences/iact/iachome.htm.
Date created: Aug. 22, 2005 |
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