CTD Format for Traditional Herbal Medicinal Products

In August 2012 the EMA already published the draft of the HMPC Guideline on the use of the CTD (Common Technical Document) format for the registration of traditional herbal medicinal products.

This guideline is intended to help applicants submitting the documents required.

Appendix 1 contains a so-called "Best Practice Guide" which should help the applicants finding the exact location of relevant parts in the CTD Module 3 on quality (chemical/pharmaceutical/biological).

For more information please see the complete Draft Guideline on the CTD format for traditional herbal medicinal products.