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EU herbal medicine product specs, efficacy guidelines needed -- EMEA rep.

This article was originally published in The Tan Sheet

Executive Summary

EU HERBAL MEDICINAL SPECIFICATIONS GUIDELINE "CRUCIAL," Konstantin Keller, PhD, director and professor, BfArM, Germany, said in a session on European regulation of herbal medicines at the recent Drug Information Association annual meeting in Boston. Speaking on behalf of the European Agency for the Evaluation of Medicinal Products Ad Hoc Working Group on Herbal Medicinal Products, Keller noted that at a recent meeting in March, the group "started a discussion on the need for guidance for specifications and we found this will be a crucial guideline." He noted there is an International Conference on Harmonization guideline on specifications, "but it is devoted to new substances."

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