EMA Publishes Concept Paper on using CTD Format in Traditional Herbal Medical Products Applications
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This concept paper is concerned with the revision of the guideline on the use of the Common Technical Document (CTD) format in the preparation of a registration application for traditional herbal medicinal products (EMEA/HMPC/71049/2007).
This revision pertains to the presentation and content of the Module 3 on Quality (chemical, pharmaceutical and biological information) for traditional herbal medicinal products (THMPs) to help future applicants in their submission.
This guideline is applicable to applications for traditional use registration of THMPs for human use.
The compilation of dossiers for marketing authorisation applications for HMPs is not covered by this guideline. However, guidance provided on modules 2.3 and 3 are also applicable to HMPs applications for marketing authorisation for human and veterinary use.
In the light of experience, there is a need to update this guideline to provide further clarification on the exact location of quality data requirements in the Module 3 on Quality of the CTD and to provide further explanations on the kind of information that is required from applicants at time of application.
Minor changes in the body of the current guideline will be introduced and two annexes will be added. The first annex will be a best practice guide describing the exact location of relevant parts of the documentation and the corresponding guidelines in the CTD Module 3 sections and the second annex will be a Module 3 mock-up.
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