CDER
Report to the Nation: 2004
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of Contents
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3 International Activities
Index
President’s Emergency Plan for AIDS
Relief
The 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:
n
Prevention of HIV transmission.
n
Treatment of AIDS and associated conditions.
n
Care, including palliative care, for HIV
infected-individuals and care for orphans and vulnerable
children.
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 That same month, we published a draft
guidance encouraging manufacturers to submit applications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:
n
Outreach activities.
n
Expedited application review and manufacturer
assistance.
n
Inspections.
n
Post-marketing monitoring.
3-drug regimen eligible 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 consisted of
co-packaged lamivudine/zidovudine fixed-dose combination
tablets and nevirapine tablets.
Generic drugs eligible for purchase under president’s
plan
As of July 22, 2005, we had
tentatively approved these generic drugs:
n
Efavirenz
n Lamivudine
n Nevirapine
n Stavudine
n Zidovudine
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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 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.
Electronic Common Technical Document
Electronic 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 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 8, 2005, we had:
49 final guidances
n
13 safety
n 3 joint safety/efficacy
n 15 efficacy
n 18 quality
8 draft guidances
n
2 safety
n 1 joint safety/efficacy
n 3 efficacy
n 2 quality
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Information-Sharing Agreements
Because 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 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 Agency for the Evaluation of Medicinals
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 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.
Switzerland
The 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 Scheme
As 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.
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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 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: Aug. 22, 2005