New EMEA Guidelines for Herbal Medicinal Products

 
On 1 October 2006 the following two EMEA HMPC Guidelines are supposed to become effective:

1. CPMP/QWP/2820/00 Rev.1

Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products

This Guideline describes the general principles for determining and justifying uniform specifications for herbal starting materials and herbal medicinal products. The complete document is available here.

2. CPMP/QWP/2819/00 Rev.1

Guideline on quality of herbal medicinal products/traditional herbal medicinal products

The important items of this guideline are:

• Qualitative and quantitative particulars of the active substance(s) of a herbal medicinal product
• Description of the method of preparation of the herbal medicinal product
• Control of starting materials
• Control tests on herbal medicinal products
• Stability Tests

This guideline is available here.
 

 
Author:
Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)