EU herbals non-clinical testing unnecessary with long marketing history -- working group.
This article was originally published in The Tan Sheet
Executive Summary
EU HERBALS NON-CLINICAL TESTING UNNECESSARY WITH LONG-TERM USE in humans, the European Agency for the Evaluation of Medicinal Products Ad Hoc Working Group on Herbal Medicinal Products proposes in a document released Jan. 28. "Where there is sufficient experience available in humans, single-dose and repeated dose toxicity, immunotoxicity as well as local tolerance testing of well-established herbal drug preparations is not necessary," the proposal says. "Likewise, pharmacological tests including safety pharmacology and pharmacokinetics are not necessary." The proposed guidance is intended to "facilitate mutual recognition and use of bibliographic data" for herbal preparations in the European Union. Comments are being accepted by EMEA through April.