[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]
BILLING CODE 4160-01-F