Principles and Practice of Pharmaceutical Medicine

EU. The following definitions are from the Gui-
dance CPMP/QWP/2820/00:

1.Herbal medicinal productsare medicinal pro-
ducts containing exclusively herbal drugs or
herbal drug preparations as active substances.

2.Herbal drugsare mainly whole, fragmented or
cut plants, part of plants, algae, fungi and lichen
in an unprocessed state, usually in dried form
but sometime fresh. Certain exudates that have
not been subjected to a specific treatment are
also considered as herbal drugs. Herbal drugs
are precisely defined by the botanical scientific
name according to the binomial system (genus,
species, variety and author).

3.Herbal drug preparationsare obtained by sub-
jecting herbal drugs to treatments such as
extraction, distillation, expression, fractiona-
tion, purification, concentration or fermenta-
tion. These include comminuted or powdered
herbal drugs, tinctures, extracts, essential oils,
expressed juices and processed exudates.

Differences in criteria and methods of assessment
of the characteristics and properties of herbal
products may represent a risk for consumers and
an obstacle to their free circulation within the
Community. Therefore, in 1997, an ‘ad hocwork-
ing group’ was established at the EMEA, which
was tasked with addressing the problems of
demonstration of quality, safety and efficacy. Sub-
sequently the group became a permanent Working
Party of the CPMP and developed a set of guide-
lines on the requirements and assessment of herbal
medicines.
The revised legislation (Regulation 726/2004)
established a new committeewithin the structure of
the EMEA named the Committee on Herbal
Medicinal Products (HCMP). This committee has
the task to provide ‘the MS and the institutions of
the Community with the best possible scientific
advice on any question relating to the evaluation
of the quality, safety and efficacy of medicinal
products’, as well as advising interested parties
on the conduct of the various tests and trials neces-
sary to demonstrate quality, safety and efficacy.

The complex composition of herbal medicines

makes quality a fundamental and critical aspect,

that have been dealt with in two guidelines:

1.Note for Guidance on Quality of Herbal Med-

icinal Products– CPMP/QWP/2819/00.

2.Note for Guidance on Specifications: Test Pro-

cedures and Acceptance Criteria for Herbal

Drugs, Herbal Drug Preparations and Herbal

Medicinal Products– CPMP/QWP/2820/00.

The first guideline addresses special quality

issues of herbal products because of the differ-

ence to products containing chemically pure,

well-defined active substances. This document

should be read in conjunction with Annex 7

‘Manufacture of Herbal Medicinal Products’of

Volume 4 of the Rules governing Medicinal Pro-

ducts in the EU. GMP recommendations should

be respected and consistent quality can only be

assured when

starting materials are defined in a rigorous and

detailed manner, including the specific botanical

identification, geographical origin and the con-

ditions under which the herbal drug is obtained

and

the manufacturing process of the finished pro-

duct, starting from a herbal drug or a herbal drug

preparation is described in a detailed manner,

including in-process controls with details of test

procedures and limits, as defined in the ‘Note for

Guidance on Manufacture of the Finished

Dosage Form’ (Vol. 3 of the Rules governing

Medicinal Products in the EU).

The second guideline provides the general princi-

ples for setting specifications for herbal drug pre-

parations, as required to build up an application for

a MA of a herbal medicinal product. The docu-

ment, therefore, defines the criteria to be followed

and reportsa listof physicochemical and biological

tests relevant for an overall quality control strategy

and consistency of quality and characteristics of

herbal drugs, herbal drug preparations and herbal

medicinal products.

34.11 HERBAL MEDICINAL PRODUCTS 469