Herbal medicinal products in the European Union - AESGP

proposals for revision
• Comments on Part 4 of Annex to Council Directive 75/318/EEC if 20 May 1975
“Clinical documentation”
• Proposal for a core-SPC for Valerianae radix (7 July 1998)
These six documents were released for consultation by the EMEA in January 1998.
The deadline for comments was April 1998.
The release of final proposals took place on 17 September 1998, under the number
EMEA/adhocHMPWG/114/98
• Proposal for new guidance “Fixed combinations of herbal medicinal products with
long term marketing experience” – Guidance to facilitate mutual recognition and
use of bibliographic data
• Comments and proposals for revision of the Notice to Applicants Volume 2B Parts
IC1 and II, including a proposal for tabular formats specific to herbal medicinal
products
These two documents were released for consultation by the EMEA in September 1998.
The deadline for comment is December 1998.
Table 1: Documents Prepared by the ad hoc Working Group on Herbal Medicinal
Products
V.3 The Role of Scientific Monographs
In 1989, ESCOP was founded by the national scientific associations of phytotherapy and
given the mission to provide scientifically based assistance for a harmonised assessment of
herbal medicinal products. The main objectives of this European umbrella organisation
have been as follows:
• to establish harmonised criteria for the assessment of herbal medicinal products;
• to provide support for scientific research; and
• to contribute to the acceptance of phytotherapy at the European level.
ESCOP also writes monographs for individual plant drugs, primarily focusing on those
plant drugs for which European or national pharmacopoeia monographs exist. To be in line
with the requirements of EC Guidelines, the format of a Summary of Product Characteristics
(SPC) was chosen for these texts. Clinical aspects and details of the pharmacological
properties are particularly highlighted. To date, ESCOP has published 50 monographs and
submitted them to the Ad Hoc Working Group on Herbal Medicinal Products. These
monographs represent an overview of the current scientific data on each medicinal plant,
but they are not intended to eliminate the need for an expert report or documentation.
Based on its “Guidelines for the Assessment of Herbal Medicines”, (Geneva, 1991), which
defined basic criteria for the evaluation of quality, safety and efficacy of herbal medicinal
products, the WHO’s Traditional Medicine Programme (TRM) has prepared a technical
document entitled “Model Monographs of Widely Used Medicinal Plants”. These
monographs include summaries of botanical characteristics, quality control and major
active chemical constituents as well as clinical applications, pharmacology, posology,
contra-indications and adverse reactions. Publication of these monographs is scheduled for
the near future.
In November 1997, the Ad Hoc Working Group on Herbal Medicinal Products concluded that
drafting “core-SPCs” would be the most appropriate way of developing general criteria for
assessing the efficacy data provided in the bibliographic documentation. General agreement
had already been reached during discussions about a core-SPC for Valerianae radix that had
been based on a proposal submitted by ESCOP. The Working Group had further proposed a n
amendment to the Notice to Applicants (The Rules Governing Medicinal Products in the
European Union), stating that scientific monographs (e.g., those drafted by ESCOP and
WHO) “offer a valuable and updated overview on published scientific literature, which
together may be used in support of the proof of safety and efficacy of a medicinal product in a
bibliographic application in accordance with Article 4.8 (a) (ii). These monographs may
avoid duplication of work and bring about gradual harmonisation in the evaluation of
medicinal products, e.g. herbal medicinal products. Therefore the European Commission
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