EU creating herbals summary for use as mutual recognition guidance.
This article was originally published in The Tan Sheet
Executive Summary
EU DEVELOPING HERBAL SUMMARY OF PRODUCT CHARACTERISTICS (SPCs) for use as guidance documents for companies seeking mutual recognition approval of herbal medicinal products in Europe. The European Medicines Evaluation Agency's Ad Hoc Working Group on Herbal Medicinal Products is creating "core" SPCs "to develop general guidance on criteria to assess efficacy data based on bibliographical documentation," EMEA said.