CDER
Report to the Nation: 2005
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of Contents
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3 International Activities
Index
President’s Emergency Plan for AIDS
Relief
To meet our
responsibilities to our own citizens we must increasingly
look, think and act globally. We participate in
harmonization committees. We are involved in bilateral and
multilateral efforts to leverage scientific and financial
resources with other nations to avoid duplication of effort
and to cooperate in focusing 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:
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Prevention of HIV transmission.
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Treatment of AIDS and associated
conditions.
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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 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 also are
engaged in outreach activities, manufacturer assistance, inspections
and postmarketing monitoring.
President’s plan focus countries
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Botswana
n
Cote d’Ivoire
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Ethiopia
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Guyana
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Haiti
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Kenya
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Mozambique
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Namibia
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Nigeria
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Rwanda
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South Africa
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Tanzania
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Uganda
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Vietnam
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Zambia
3-drug regimen gets tentative NDA approval for
purchase under president’s plan
In January 2005, within two weeks of receiving a
complete application, we tentatively approved a complete three-drug
product. It consisted of co-packaged lamivudine/zidovudine
fixed-dose combination tablets and nevirapine tablets. We also
approved a generic version of this regimen.
Generic drugs eligible for purchase under
president’s plan
As of June 29, 2006 we had fully approved two
generic drugs and tentatively approved another 19. A list and more
information is at
http://www.fda.gov/oia/pepfar.htm.
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Information-Sharing Agreements
Because of enhanced cooperation among
regulators around the world, FDA has entered into
international agreements in which we play a critical
implementation role. We have a growing list (left) 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. Examples or our agreements include:
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 inspection findings into a risk-based program for
future inspection.
European Medicines Agency (EMEA)
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 in 2005.
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 agreements
n
Countries
o
Australia
o
Canada
o
France
o
Germany
o
Ireland
o
Israel
o
Japan
o
Mexico
o
Singapore
o
Sweden
o
Switzerland
o
South Africa
o
United Kingdom
n
Organizations
o European Medicines Agency (EMEA)
o
World Health Organization (WHO)
International regulators forum
In 2005, we held the first of a series of twice
yearly week-long forums with international regulators. There were 27
representatives from all but one of the 15 PEPFAR focus countries,
19 from seven other African and Asian countries and three from the
World Health Organization. We provided information about U.S. drug
regulatory processes and shared perspectives on approaches to common
regulatory and scientific challenges.
Pharmaceutical Inspection Cooperation Scheme
As part or of our initiative to improve
manufacturing practices,
FDA applied for membership in this international organization
dedicated to drug regulatory harmonization and collaboration in the
area of good manufacturing practices.
CGMP workshop in China
To foster compliance with current good
manufacturing practices, we co-sponsored an educational public
workshop in collaboration with Peking University and the
International Society for Pharmaceutical Engineering.
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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
practices. 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.
Export certificates
We issue export
certificates that verify the drug products being exported:
n
Were freely marketed in the United
States.
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Were in compliance with U.S. laws and
regulations.
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Met certain national or international
standards, such as quality standards.
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Were free of specific contaminants.
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text.
Drug imports
Agency resources are
particularly focused on counterfeit drugs and counterterrorist
activities. We work to:
n
Enforce the law.
With FDA’s field force, we enforce legal requirements determining
which drug products may be imported by manufacturers, distributors
and consumers.
n
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.
n
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
n
234 preapproval inspections in
support of:
o
143 new drug applications
o
120 generic drug applications
n
213 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. Our review of
263 inspection requests for foreign establishments, resulted in
three warning letters, two import alerts and several regulatory
meetings.
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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 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 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.
Click here for
accessible description.
Internet resource
More information is on the ICH Web site at
http://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:
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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.
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Download files so submissions can be
used even when the reviewer is off the network.
Harmonization guidances
We 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 12, 2006, we had:
n
55 final guidances
o
16 efficacy
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3 joint safety/efficacy
o
21 quality
o
15 safety
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5 draft guidances
o
3 efficacy
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2 joint safety/efficacy
Internet resources
More information about our international activities,
including Spanish language materials, is at http://www.fda.gov/cder/audiences/iact/iachome.htm.
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Date created: August 18, 2006 |