FDA
TALK PAPER

T97-25                     Don McLearn      (301) 827-6242
June 16, 1997              
                           Consumer Hotline:(800) 532-4440       
                             

                   FDA'S NEGOTIATIONS WITH EU
     The United States and the European Union (EU) have concluded
negotiations on a package of Mutual Recognition Agreements
(MRAs).  The package is composed of a "framework agreement" and
six sub-sections containing specific provisions indicating the
products and activities covered.  There has been increased
interest by the media in FDA's role in the United States' efforts
to negotiate MRAs with the EU.  The following can be used to
answer questions:
     The agreements would allow FDA and its EU counterparts to
exchange reports on inspections of pharmaceutical and medical
device production facilities.  In addition, the agreement dealing
with medical devices provides for the exchange of product
evaluation reports of medical devices by third parties in the
United States and EU, under the existing FDA pilot program for
selected medical devices.  These reports will normally be
accepted and used by the receiving regulatory authority.  The
requirements to be met by manufacturers are the importing
country's standards.
     In terms of inspections, the agreements cover pharmaceutical
and medical device production facilities in the EU from which
products are exported to the United States, and vice versa. All
of these facilities have to be inspected for compliance with the
good manufacturing practices (in the case of pharmaceuticals) and
quality system requirements (in the case of medical devices).
     Currently, FDA and the EU regulatory bodies conduct hundreds
of such overseas inspections annually, at considerable expense to
their taxpayers.  Under the agreements when fully implemented,
FDA and its EU counterparts would each inspect the appropriate
domestic production facilities and make sure they are in
compliance with the regulations of the country to which they
export.  It is anticipated that, over the long term, both parties
to the agreement could streamline their processes and save
considerable resources while enhancing their public health
standards.
     FDA's readiness to participate in such agreements is
predicated on demonstrated equivalence of the EU inspectional
processes with those of the agency.  FDA must also be confident
that the good manufacturing practices standards applied to the
EU's pharmaceutical industry are equivalent to those used in the
United States.  Equivalence would be assessed during a three-year
transition period during which both parties would cooperate on
various activities (e.g., exchange of inspection reports, joint
inspections and joint training).  Each party would retain the
right to conduct its own inspections, if it regards it as
necessary.
     For both inspections and for device premarket review, the
paramount rule is that each party retains full responsibility for
products marketed in its own country and can take action
necessary to protect the public health. Thus, the regulatory
authorities and bodies of the exporting countries will measure
manufacturers' compliance according to the requirements of the
importing country.
     The agreement pertaining to medical devices also contains
the following highlights:
o     It provides for premarket review of designated low and
medium risk products in parallel with FDA's domestic third party
pilot program.  Authorized European organizations -- called
"notified bodies" -- could review 510(k) applications against
U.S. requirements, and submit the reviews to FDA for final
action.
o    FDA would prepare written guidance on product testing
requirements to help assure review consistency for medical
devices.
o    After a three-year transition period, there must be a
consensus decision on which European notified bodies have
demonstrated proficiency to conduct product reviews in a manner
consistent with FDA standards.
     The agreement that pertains to pharmaceuticals also contains
the following highlights: 
o    A set of criteria to be used to determine whether the
regulatory systems are equivalent for pre-and post-approval
inspections.  
o    At the end of the three-year transition period, there must
be a consensus decision as to which regulatory authorities have
in place an equivalent regulatory system in accordance with the
criteria. 
     The agreements also contain provisions for addressing issues
or problems through FDA co-chaired committees, and for the
establishment by the two parties of an early warning system to
exchange emerging information on post-marketing problems with a
drug or medical device.  The "framework" agreement contains a
provision for maintaining the confidentiality of, and providing
public access to certain information.
     FDA plans to publish, sometime in the near future, the parts
of the MRA package relevant to the agency in the Federal Register
for public notice and comment.

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