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The Commission E Monographs |
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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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