New EMA Guideline on Specifications for Herbal Medicinal Products
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
On 28 September 2011, the EMA published a document entitled "Guideline on Specifications: Test Procedures and Acceptance Criteria for Herbal Substances, Herbal Preparations and Herbal Medicinal Products / Traditional Herbal Medicinal Products".
Compared to the previous, only small changes have been made. Not only new or revised guidelines have been taken into account but also the revised "Herbal Drugs" Monograph from the European Pharmacopoeia as well as new requirements regarding impurities.
The structure of the guideline itself hasn't changed.
Please see the revised "Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products" for further information.
PS: The monograph "Water for Preparation of Extracts" (04/2012:2249) has now been included in version 7.4 of the European Pharmacopoeia.
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
Related GMP News
03.09.2026USP Article: Supporting the Detection of Asbestos in Pharmaceutical Talc
02.09.2026USP Publishes Comments Received on Chapter <320>
26.08.2026New USP Requirements for Asbestos Testing in Pharmaceutical Talc
19.08.2026FDA Warning Letter: Averaging Data to Override OOS Findings
12.08.2026ECA's Analytical Control Group Publishes Detailed Report on OOS Survey
12.08.2026BP Publishes Key Insights on Limits in Chromatographic Tests