FWD 2 Commission E: Recent Changes at Commission E

  The Commission E Monographs



THE COMPLETE GERMAN COMMISSION E MONOGRAPHS
THERAPEUTIC GUIDE TO HERBAL MEDICINES
Copyright © 1999 American Botanical Council


Part One Introduction
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Recent Changes at Commission E

Since 1995 Commission E has not issued any new monographs. The new role of the Commission is to act as a Commission for Registration for phytomedicines to be sold on a prescription basis and also to participate in making decisions concerning the extension of registrations of nonprescription phytomedicines, (such as post-registration approvals (Schulte, 1995).

With no new monographs being produced, the Kooperation Phytopharmaka is collecting new studies published subsequent to the approval of the Commission E monographs. The new data are being submitted for consideration in the preparation of ESCOP monographs and are also being considered by BfArM in determining the licensing and registration of phytomedicinal drug products. The licensing requirements stipulate that scientific material on phytomedicines undergoing license review must be up-to-date (Schilcher, 1998c).

The purpose of Commission E now is to act mainly as a highly authoritative advisory board to the BfArM to review individual applications for phytomedicines seeking market authorization in Germany. The status of a phytomedicine's having a positive monograph is no longer sufficient to constitute registration of an herbal drug. The Commission will continue to consider if the documentation based on a positive monograph is sufficient for the registration of an herbal drug in Germany. If external experts and the Commission agree that the data in a product registration is up-to-date and accurate, then the BfArM has the choice of approving the registration. If the BfArM does not agree with the Commission's evaluation, then it must justify its position in a public report. To date, this situation has not occurred; the BfArM has always agreed with the Commission's assessments so far (Schilcher, 1998a).

Of the phytomedicines registered according to the Second Medicines Act since 1994, 610 of these are based on a positive Commission E monograph (Schilcher, 1998a). Thus, even in the view of external experts, the positive monographs are still up-to-date (Schilcher, 1997b).

There is additional interest in development of therapeutic monographs outside Germany by ESCOP even though the ESCOP monographs are scientific but not official government publications. With no new monographs being produced or revised by Commission E, and with the eventual expansion of the European Union's efforts to harmonize drug regulations throughout Western (and perhaps Eastern) Europe, the Commission E monographs will become a matter of historical documentation and a basis for the scientific documentation of herbs and phytomedicine in the future.



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