EU, FDA Work Toward Harmonization

Nov 20, 2007 | Contact Author | By: Rachel Chapman
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Title: EU, FDA Work Toward Harmonization
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The Transatlantic Economic Council (TEC) meeting, held Nov. 9, 2007, in Washington, D.C., made an important step forward in harmonization between the European Union (EU) and the US Food and Drug Administration (FDA). The meeting aimed to reduce regulatory barriers to trade, protect intellectual property rights, ensure secure trade, integrate financial markets, promote innovation and technology and encourage investment. 

According to the European cosmetics industry association, Colipa, the TEC was created by EU and US leaders to foster transatlantic economic integration at the EU/US Summit in Washington in April 2007. Colipa welcomed the inclusion of cosmetics as a priority sector in the TEC process in a press announcement, stating that it strongly believes this initiative can help to promote the alignment of cosmetics regulations.

“The cosmetics industry needs a global regulatory environment that allows innovation, secures competitiveness, recognizes and supports efforts in the field of science and research, and actively contributes to consumer confidence,” stated Bertil Heerink, director general of Colipa, in the announcement.

Reportedly, a special focus was given to the development of alternatives to animal testing and the need to intensify efforts internationally to ensure effective validation and acceptance of alternative testing methods.

"The important step [forward, as a result of this meeting] is that the European Commission and the United States have agreed to cooperate more closely in the peer review of validation studies of alternative methods to animal testing for cosmetics, which should contribute to reduce animal tests," Sebastian Marx, director of communications and public affairs for Colipa, told C&T magazine.

"This cooperation is of utmost importance for the cosmetics industry in the light of the upcoming deadlines for introducing alternative test methods in Europe, " added Marx. He noted that in order to meet these obligations, the industry needs to develop alternative testing methods that are validated and accepted by scientists and authorities worldwide.

“This poses a range of challenges for industry, academia, regulators and validation authorities together. We hope that the TEC process can contribute to speed up the validation and acceptance of alternative methods internationally in the coming years," said Heerink, in Colipa's press statment.