[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)]
[Notices]
[Pages 21194-21195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11517]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95S-0181]
U.S.-European Union Mutual Recognition Agreement Activities;
Pharmaceutical GMP's and Medical Devices; Establishment of a Public
Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a public docket through which it will make available
information concerning its participation in bilateral Mutual
Recognition Agreement (MRA) talks in the areas of pharmaceutical GMP's
and medical devices being led by the Office of the U.S. Trade
Representative (USTR) and the Department of Commerce (DOC) and by
representatives of the European Commission.
ADDRESSES: Documents concerning FDA's bilateral MRA talks are available
for public examination in the Dockets Management Branch (HFA-305), Food
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD
20857, between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Walter M. Batts, Office of
International Affairs (HFY-50), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4480.
SUPPLEMENTARY INFORMATION: The U.S. Government, led by USTR and DOC, is
engaged in formal talks with the European Union (EU), led by
Directorate-General I (External Relations) of the European Commission.
The EU initiated these talks to facilitate access to foreign markets
for their products and to facilitate access to the EU market for
foreign products. The EU indicated that the latter purpose was in
response to concerns raised by foreign countries, including the United
States, that the ``Single Internal Market by 1992'' program would
result in a ``fortress Europe'' that would disadvantage foreign firms.
The EU is also pursuing separate MRA talks with other countries,
including Canada, Australia, and Japan.
As a result of an EU request to identify products to be covered by
the MRA talks and their proposal that pharmaceuticals and medical
devices be included, the U.S. Government with support by the industry
agreed that pharmaceuticals, GMP's, and medical devices should be among
those areas included in the talks. FDA's discussions with the EU cover
GMP's for human and animal drugs, human biologicals, and medical
devices.
In 1989, prior to the initiation of the MRA talks by Directorate-
General I, USTR, and DOC, FDA and Directorate-General III (Industrial
Affairs) of the European Commission decided to begin discussions that
may lead to an agreement in the pharmaceutical good manufacturing
practices (GMP's) and medical devices area. FDA's primary motivation in
seeking such an agreement was at that time, and still is, a desire to
most effectively utilize limited resources. FDA recognized the
[[Page 21195]]
value of pursuing such agreements with selected foreign regulatory
bodies in its 1992 ``Report of the Task Force on International
Harmonization.'' The task force concluded that the development of
memoranda of understanding (MOU's) is an effective means of
facilitating international harmonization; of ensuring the safety,
efficacy, and/or quality of products that are offered for import into
the United States; and of efficiently using agency inspectional
resources. The task force, however, cautioned that the negotiation of
MOU's must be with foreign regulatory agencies that have appropriate
authority and expertise to ensure the proper implementation of any MOU
that may be agreed upon. A properly conceived and executed agreement
with the European Commission would permit the use of EU Member State
government inspectional information to assist FDA in its regulatory
decisionmaking and could help to set priorities for foreign inspection
or import surveillance programs. Early initiatives to pursue an MOU
with the European Commission did not receive high priority by either
side. Recently the MRA talks have served as a catalyst for
reinvigorating these discussions.
The talks have been led by USTR and DOC with the Directorate-
General I as their counterpart office in the European Commission. There
have been six rounds of talks to date, beginning in April 1994. The
most recent round of talks was held in Washington, DC, from November 13
through 15, 1995. FDA has participated in each round of discussions.
To provide an opportunity for public input into the pharmaceutical
GMP discussions with the European Commission and the Member States, FDA
hosted a public exchange meeting on March 31, 1995. The meeting was
attended by approximately 40 persons representing the drug and
biologics industries, consultants, and other organizations. Attendees
expressed support for, as well as concerns regarding, the proposed
agreement.
A delegation of FDA officials attended a pharmaceutical GMP
workshop hosted by the European Commission in Brussels from April 3 to
5, 1995. The purpose of the meeting was to exchange information on
inspection programs in the United States and the EU, and how each of
the EU Member States carries out its role. The Canadian Health
Protection Branch also attended the meeting and made a presentation on
their pharmaceutical GMP program. At the conclusion of the workshop it
was agreed that further cooperative efforts are needed before we could
develop an MRA or MOU. Such efforts could include exchange of
inspection reports, joint inspections, joint training of inspectors,
and development of a joint inventory of facilities requiring
inspection.
Also, following the conclusion of the workshop, industry
representatives from the EU and the United States were invited to
express their views. Both sides expressed support for an agreement. The
U.S. pharmaceutical industry generally expressed the desire for a
harmonized approach. The EU pharmaceutical industry expressed a desire
for an approach that provided for mutual recognition of the current
systems.
On May 1, 1995, a delegation of FDA officials also participated in
meetings with EU officials and notified body representatives to allow
both sides to better understand their respective medical device
regulatory regimes. In addition to useful exchange of information and
``confidence building,'' the meetings helped to clarify several
technical issues related to an MRA on medical devices.
Through this notice, FDA is establishing a public docket in order
to make available at a convenient location certain information
concerning its participation in these bilateral MRA talks. Information
currently contained in this public docket includes the following:
Minutes of the FDA-sponsored public exchange meeting held on
March 31, 1995.
Agenda of FDA-sponsored public exchange meeting held on March
31, 1995.
Statements of participants presented at the FDA-sponsored public
exchange meeting held on March 31, 1995.
Summary of the April 3 through 5, 1995, Pharmaceutical GMP
Workshop in Brussels.
Summary of the July 10 through 12, 1995, MRA talks in Brussels
concerning pharmaceutical GMP's.
FDA summary of November 13 through 15, 1995, round of
negotiations.
Presentation of Walter Batts entitled ``Mutual Recognition
Agreement Negotiations with EU re: Pharmaceutical GMP's-FDA's
Perspective,'' February 13, 1996.
Dated: May 1, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-11517 Filed 5-8-96; 8:45 am]
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