a key element of the EU-U.S. Positive Economic Agenda, U.S.
and European Commission (EC) authorities continue to promote EU-U.S. regulatory
cooperation, in particular through implementation of the EU-U.S. Guidelines for
Regulatory Cooperation and Transparency as negotiated under the Transatlantic
Economic Partnership (TEP). Implementation of the Guidelines has yielded good
progress in a number of regulatory areas, but the scope for potential EU-U.S.
cooperation is far broader.
addition to pursuing current
regulatory cooperation projects, we are working to identify additional specific
cooperative projects, as well as horizontal initiatives and possible
improvements to the scope and
of the Guidelines. We will also endeavour to clarify the role of the Guidelines
as a policy tool for EU and U.S.
regulators in order to help our regulators to define their own efficient
approaches for promoting effective regulatory cooperation.
EU-U.S. roadmap outlines some specific regulatory cooperation activities we
jointly intend to pursue during the next year. Our work will evolve as each side
continuously examines other areas of mutual interest for regulatory
co-operation, and considers input from interested transatlantic stakeholders.
The TEP Steering Group reviews the implementation and
functioning of these Guidelines, as well as progress on regulatory co-operation
on an ongoing basis.
Cooperation between Food and Drugs Administration (FDA), DG
Enterprise/Pharmaceuticals Unit and the European
the Evaluation of Medicinal Products (EMEA) on matters related to ensuring
the safety, quality, and efficacy of pharmaceutical
the exchange of information and data on pharmaceuticals as agreed under
the September 2003 arrangement between FDA, DG Enterprise and the European
Agency for the Evaluation of Medicinal Products (EMEA). As part of this
engage in parallel scientific advice; promote scientific personnel exchanges and
joint meetings; share respective draft guidance on drug safety issues,
including adverse reactions; and examine cases where
and EU authorities have adopted different approval decisions for specific drugs
("benchmarking exercises"). Consider
additional issues for possible cooperation.
Cooperation between the U.S. National Highway Traffic Safety Administration
(NHTSA) and DG Enterprise/Automobile Unit in areas of auto safety regulations.
Develop agreed workplans for the specific regulatory projects to be pursued
under the NHTSA-DG Enterprise regulatory dialogue created under the June 2003
Information and Communications Technology Standards
Identify and pursue information exchange on the use of information and
technology (ICT) standards in support of regulations.
Pursue cooperation on specific projects identified under a new EU-U.S. dialogue
in March 2004 and coordinated by the Commerce Department
and DG Enterprise. Initial projects under this dialogue include e-accessibility,
security, and biometrics.
Cooperation between the U.S. Food and Drug Administration (FDA) and DG
Unit regarding: (a) alternative (i.e.,
respective regulatory approaches applied in the area of hair dyes; and (c) other
of mutual interest.
regulatory cooperation activities as outlined in agreed 2003 project
Identify possible new areas for cooperation as part of the Cosmetics
and International Cooperation (CHIC) process
5. Consumer Product
Cooperation between the U.S. Consumer Product Safety Commission (CPSC)
and DG SANCO regarding safety notices and corrective actions of hazardous
an arrangement between CPSC and DG SANCO to facilitate the sharing
of data/information from the RAPEX System. RAPEX serves as a single rapid
system for dangerous consumer products in Europe. All non-food products intended
consumers, or likely under reasonably foreseeable conditions to be used by
are included within the scope of RAPEX, with the exception of pharmaceutical
Cooperation between FDA and DG SANCO on issues of mutual interest in
field of nutritional labeling.
Compare scope of nutritional labeling requirements in the United States and the
EU. Identify specific activities for cooperation on technical issues such as
for nutrient labeling, nutrient definitions, and energy conversion
New Cooperation (open-ended)
FDA-DG SANCO Regulatory
Establish broad new FDA-SANCO regulatory dialogue. Identify specific
cooperation projects of mutual interest.
Regulatory Dialogues between the European Commission and the U.S. Government
involving European Regulatory Agencies
Examine improved regulatory co-operation in the following areas:
Establish regulatory dialogue between FDA, the European Commission, and the
European Food Safety Authority
Enhance ongoing regulatory cooperation between the European Commission and FDA
and the European Agency for the Evaluation of Medicinal Products
Explore possible new or enhanced regulatory dialogues in areas of mutual
interest between the European Commission and the U.S. Government, involving,
where appropriate, other relevant European Regulatory Agencies.
CPSC-DG SANCO Regulatory Dialogue
Explore regulatory dialogue between CPSC and DG SANCO regarding the EU's
revised General Product Safety Directive.
Explore possible cooperation between Environmental Protection Agency (EPA) and
DGs Energy and Transport, Environment and Enterprise in the area
of eco-design of energy-using products.
Additional Regulatory Discussion
informal discussions, in the spirit of the Guidelines, between the U.S.
Environmental Protection Agency (EPA), DGs Environment
and Enterprise and relevant agencies on chemicals related issues
of mutual interest.
informal discussions, where appropriate,
of mutual interest both through bilateral exchanges and in the margins of other
such as the OECD.
General Regulatory Policy – initiate a regular informal dialogue between the
relevant authorities of the European Commission and the U.S. Government on
regulatory policy issues and practices of mutual interest and consistent with
the OECD Recommendations in this area. Examples could include: practices and
procedures in regulatory processes, tools, transparency and public consultation
and impact assessment methodologies.
Regulatory Workplans -
a mechanism for regular exchange and discussion of annual
U.S. and EC regulatory workplans. Such a review could help identify additional
areas for EU-U.S. regulatory cooperation.
S.-EC Regulatory Exchanges - identify resources and mechanisms to promote
exchanges of U.S. and EC regulatory
experts in specific areas/projects of mutual
U.S.-EC Regulatory Seminar/Workshops -
seminars/workshops where U.S. and EC regulators
can exchange views and raise awareness of our respective regulatory activities,
priorities and approaches on issues of mutual interest.
Outreach Activities - identify and pursue
approaches to promote: 1) broader visibility/awareness within the USG, EC and
among transatlantic stakeholders of the Guidelines; 2) the importance of EU-U.S. regulatory
cooperation; and 3) opportunities for stakeholders to propose regulatory
cooperation activities under the Guidelines.
Consider expansion of the Guidelines' scope to:
more directly address standards-related matters;
address other regulatory activities not currently covered.
Develop a model confidentiality agreement that could be adapted, as appropriate,
to support the
sharing of confidential information under a range of EU-U.S. regulatory
cooperation projects. A model agreement, based on the existing FDA-DG Enterprise
confidentiality agreement for sharing
information on pharmaceuticals, could be formally referenced in the Guidelines
or be added
as an annex to the Guidelines.
Identify possible improvements to Guidelines provisions that could further
enhance its effectiveness
and its role as a mechanism intended to support a broad range of EU-U.S.
regulatory cooperation in areas of mutual interest.