New HMPC Concept Papers published on Herbal Medicinal Products

Global Registration and Life Cycle Management for APIs

Recommendation

8-10 April 2025
Vienna, Austria

Global Registration and Life Cycle Management for APIs
Contents of the regulatory information in the ASMF and CEP

EMA's HMPC (Committee on Herbal Medicinal Products) published two new concept papers on 1 June 2015.

One is on the revision of the guideline on specifications, test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products.

The revision is required in order to take into consideration the updated Q&A document on the quality of herbal medicinal products. And new guidance from the European Pharmacopoeia must be considered.

The other one is a revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal products.

Here again, it is important to adapt to the European Pharmacopoeia and to the updated Q&A document. Furthermore, the Guideline on declaration of herbal substances and herbal preparations has to be taken into account.

Deadline for comments for both documents is the 31 August 2015.

For more detailed information please see the complete Concept Paper on the revision of the guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products as well as the second Concept Paper on the revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal products.