The US Food and Drug Administration (FDA), the European Commission (EC),
and the European Medicines Agency (EMEA) have agreed to expand their
current cooperative activities in several important areas. At a meeting
June 14-15, 2007, the US and the EU reviewed the past year's activities
under the existing Implementation Plan for the confidentiality
arrangement. The ultimate goal of the initiative is to promote and
protect public health, reducing regulatory burden and costs, and
bringing innovative products to patients in a timely manner.
Furthermore, important safety information about medicinal products is
shared among the parties.
Building on the achievements in cooperation on vaccines, oncology, and
pharmacogenomics, it was agreed to expand further the interactions in
the areas of pediatrics and medicinal products for rare diseases
("orphan drugs"). Furthermore, scientific dialogue has been widened to
include extensions of therapeutic indications and risk management plans.
Based upon the newly adopted pediatric legislation in the EU, a
"Principles of Interactions" document that will facilitate the timely
exchange of information on scientific and ethical issues for pediatric
therapeutics has been finalized and can be found
here.
The Implementation Plan on transatlantic medicines regulatory
cooperation was revised to better describe the specifics of what
information will be shared among the parties and under what
circumstances, and the revised Plan has been finalized.
Click here .
Following the Framework for Advancing Transatlantic Economic Integration
between the EU and the USA, new areas of transatlantic regulatory
cooperation were discussed notably regulatory cooperation on medical
devices and on cosmetics. Discussions on the best ways to cooperate in
these areas will continue intensively over the coming months.
In an effort to avoid future disharmony, upstream regulatory cooperation
on new medicines legislation was intensively discussed. In addition,
planning progressed on a Transatlantic Workshop on Administrative
Simplification in Medicines Regulation. This workshop will be held on 28
November 2007 in Brussels, Belgium.
Transatlantic regulatory cooperation under the EC, EMEA and US FDA
collaboration has allowed each side to share common experiences and gain
an understanding of each other's regulatory system. Additionally, each
side strives to reduce unnecessary differences in regulations and reduce
associated costs to the consumer and industry. All parties concur that
this activity continues to be a success in fostering transatlantic
cooperation and promoting public health protection.
http://www.emea.europa.eu
Publication Date: 2007-06-20 03:00
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