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CDER 2007 Update
International Activities
To meet our responsibilities to United States citizens we must increasingly look, think and act globally. We participate in harmonization committees and are involved in bilateral and multilateral efforts to leverage scientific and financial resources with other nations. This avoids duplication of effort and allows focus on high-risk areas.
President’s Emergency Plan for AIDS Relief
The president’s $15 billion plan for AIDS relief around the world has a special focus on 15 countries hardest hit by the HIV epidemic. It targets three specific areas related to HIV/AIDS:
- Prevention of HIV transmission.
- Treatment of AIDS and associated conditions.
- Care, including palliative care, for HIV infected-individuals and care for orphans and vulnerable children.
We are encouraging manufacturers to submit applications for fixed-dose combination and co-packaged versions of previously approved antiretroviral therapies. 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 means that a drug meets our standards for safety, efficacy and quality, but that existing patents or exclusivity prevent them from being sold in the United States.
We have an expedited review process to ensure that the United States could provide safe, effective and affordable quality drugs to developing countries. We encouraged U.S. and foreign firms who were developing generic drugs to treat HIV disease to apply under the president’s plan. To meet the plan’s approval timelines, our generic drug reviewers implemented many process changes, including a rolling review approach. Our average review time for these applications has been six months. We lack information about most clinical laboratories and manufacturing sites associated with the products seeking approval under the emergency plan. Therefore, we are engaged in outreach activities, manufacturer assistance, inspections and postmarketing monitoring.
15 countries in the President’s plan
- Botswana
- Cote d’Ivoire
- Ethiopia
- Guyana
- Haiti
- Kenya
- Mozambique
- Namibia
- Nigeria
- Rwanda
- South Africa
- Tanzania
- Uganda
- Vietnam
- Zambia
As of December 20, 2007, 58 generic drugs were eligible for purchase under the president’s plan. We had fully approved four generic drug products and tentatively approved another 54. More information is available at www.fda.gov/oia/pepfar.htm.
Information-Sharing agreements
With enhanced cooperation among regulators around the world, FDA has entered into international agreements in which we play a critical implementation role. Below is 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.
Countries:
- Australia
- Belgium
- Canada
- Denmark
- European Union
- France
- Germany
- Ireland
- Israel
- Japan
- Mexico
- Netherlands
- Singapore
- Sweden
- Switzerland
- South Africa
- United Kingdom
Organizations:
- European Medicines Agency (EMEA)
- World Health Organization (WHO)
Examples of our agreements
Japan and Australia
We 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 findings into a risk-based program for future inspections.
European Medicines Agency
This 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 Canada
FDA 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 a mutually beneficial direction. Exchanges of product recalls, emerging compliance issues and site-specific information have already begun. An agreement with Canada provides for the exchange of information about pending approvals, post-marketing surveillance and enforcement actions.
Switzerland
The working arrangement with Switzerland began several years ago and has continued to progress steadily. 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 as well as inspection information. Successful joint inspections have helped foster mutual confidence and improve communications.
International regulators forums
Over the years, CDER has been privileged to host many of our international colleagues interested in learning about our drug review process. In September 2005, the CDER Forum for International Drug Regulatory Authorities was established for the exchange of drug regulatory information between CDER and its counterpart agencies in other countries. Offered every spring and fall, it provides information about the U.S. drug regulatory processes in an organized and integrated manner. It explains the role of CDER as well as the science, technology, regulations and processes used to do our work.
The fifth forum was offered in October 2007. As of that date, we had provided information about the U.S. drug regulatory processes to 171 regulators from 50 countries.
Our materials are posted on the Internet so participants can share what they have learned with their colleagues; www.fda.gov/cder/audiences/iact/forum/degault.htm .
Assuring international trade quality
While the globalization of pharmaceutical commerce brings the benefits of modern drugs to citizens worldwide, it poses many challenges to us and regulators in foreign countries. We share with them a common interest in ensuring our citizens have access to safe, effective and high quality products and are protected from counterfeit drugs and terrorist threats.
Drug exports
Export certificates attest that U.S. drug products are subject to inspection by FDA and are manufactured in compliance with current good manufacturing practice. These certificates enable American manufacturers to export their products to foreign customers and foreign governments. The demand for certificates remains high due to expanding world trade, ongoing international harmonization initiatives and international development agreements.
Drug imports
Agency resources are particularly focused on counterfeit drugs and counterterrorist activities. We work to:
- Enforce the law. With FDA’s field force, we enforce legal requirements determining which drug products may be imported by manufacturers, distributors and consumers.
- Identify and interdict illegal drugs. We take steps to ensure that imported drugs are not counterfeit, unapproved, adulterated or misbranded and that they meet applicable legal requirements relating to safety and effectiveness.
- Improve technology. Along with the pharmaceutical and advanced technology industries, the states and other federal agencies, we are monitoring the development and implementation of track and trace technology that will enhance anti-counterfeiting measures by providing real-time monitoring of a drug product through the U.S. drug distribution system.
Foreign inspections
- 289 preapproval inspections in support of:
- 145 new drug applications
- 177 generic drug applications
- 238 current good manufacturing practice inspections
For most foreign inspections, both a cGMP and a preapproval inspection take place and are counted twice, once under each inspection program. We reviewed 208 inspection reports for foreign establishments to ensure compliance with good manufacturing requirements and to determine capability of producing drugs named in applications. Regulatory actions included five warning letters, two untitled letters, four import alerts and several regulatory meetings.
Export certificates
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We issue export certificates that verify drug products being exported:
- Were freely marketed in the United States.
- Were in compliance with U.S. laws and regulations.
- Met certain national or international standards, such as quality standards.
- Were free of specific contaminants.
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 (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 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.
Harmonized guidances
We publish International Conference on Harmonization documents as guidances to industry at on the topics of drug safety, efficacy and quality. These guidances may be found at: www.fda.gov/cder/guidance/index.htm.
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. Specifications for electronic submission of the CTD, known as the eCTD, were completed in 2002. More information is on the ICH Web site at www.ich.org.
Electronic Common Technical Document
Electronic submissions using the eCTD can be used to submit all applications and related submissions such as promotional materials and adverse events. Among other things, the eCTD allows reviewers to:
- Create an up-to-date, cumulative table of contents for the entire application at any time.
- Access any electronic submission from a single screen.
- Download files so submissions can be used even when the reviewer is off the network.
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Date created: July 31, 2008 |
