Updating of the HMPC-Guideline on the use of the CTD Format in the Registration of Traditional Herbal Medicinal Products

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Updating of the HMPC-Guideline on the use of the CTD Format in the Registration of Traditional Herbal Medicinal Products

Compared to herbal medicinal products (HMPs) there is a simplified registration procedure for traditional herbal medicinal products (THMP).

EMA’s HMPC (Committee on Herbal Medicinal Products) published the draft of revision 2 on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products on 10 March 2015.

This guideline contains instructions on how to prepare a CTD for a registration application of traditional herbal medicinal products.

Now, there is a new annex 2 with a mock-up which shows by means of a concrete example where and to what extent information should be given on traditional herbal medicinal products in the dossier.

Appendix 1 is a best practice guide for module 3 on quality.

For further information please see the complete draft revision 2 of the “Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products” comprising more than 151 pages together with all annexes (!).

http://www.gmp-compliance.org/enews_4880_Updating-of-the-HMPC-Guideline-on-the-use-of-the-CTD-Format-in-the-Registration-of-Traditional-Herbal-Medicinal-Products_n.html

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One thought on “Updating of the HMPC-Guideline on the use of the CTD Format in the Registration of Traditional Herbal Medicinal Products

    DR ANTHONY MELVIN CRASTO Ph.D responded:
    August 13, 2015 at 5:18 am

    Reblogged this on New Drug Approvals.

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