'Unit . . .
3
EU AND ICH GUIDELINES FOR
QUALITY CONTROL OF HE,RBAL
DRUGS
j 3.1 INTRODUCTION
The International Council far Harmonization (!CH) of technical requirements far
pharmaceuticals far human use brings together the medicines regulatory authorities and
pharmaceutical industry around the world. !CH aims to achieve greater harmonization
worldwide far the development and approval of safe, effective and high-quality medicines in
the most resource-efficient manner. The European Medicines Agency (EMA), in collaboration
with the EU Member States, supports the European Commission's membership in !CH and
plays a key role in the development and implementation of !CH guidelines. The reformed !CH
is intended to transform !CH into a truly global initiative supponed by a robust and
transparent governance structure.
EUROPEAN UNION (EU) GUIDELINES FOR QUALITY
CONTROL OF HERBAL DRUGS
The European Medicines Agency's (EMAs) Committee far herbal medicinal products for
human and veterinary use prepares scientific guidelines in consultation with regulatory
authorities in the European Union (EU) Member States, to help applicants prepare marketing
authorization applications far human and veterinary medicines. Guidelines reflect a
harmonized approach of the EU Member States and the Agency on how to interpret and
apply the requirements far the demonstration of quality, safety and efficacy set out in the
Community orders.
3.1
Quality Control and Standardization of Herbals EU and ICH Guidelines tor .....
Quality
Clinical Non-dinical
Safely of herbal
substances/products
Fig. 3.1: Scientific Guidelines on Herbal Medicinal Products
Quality
(l) Guidelines on the declaration of herbal substances and herbal preparations in
herbal medicinal products/traditional herbal medicinal products:
The declaration is proposed to describe the identity and quantity of the herbal
substance/preparation, being the active substance of the herbal medicinal product and
should focus on those characteristics found to be useful in ensuring the safety and efficacy of
the herbal substance/preparation and herbal medicinal product. Therefore, a declaration
system has been, established which reflects the main characteristics of herbal
substances/preparations as defined in the respective specifications.
(a) Standardized herbal substances: Standardized herbal substar1ces are adjusted
within an acceptable tolerance to a given content of constituents with known therapeutic
activity. Standardization is achieved by adding excipients for adjustment to the herbal
substance or by blending batches of the herbal substance. For such herbal substances, the
name and content of the constituent(s) with known therapeutic activity should be stated. The
equivalent quantity of the genuine herbal substance should be given (as a range).
(b) Quantified herbal substances: Quantified herbal substances are adjusted to a
defined range of constituents. Adjustments are made by blending batches of herbal
substances used in the manufacturing process. For quantified herbal substances. the name of
the active markers should be stated and their content should be given in a range. The
equivalent quantity of genuine herbal substance should be given.
{c) Other herbal substances: For other herbal substances, neither constituents with
known therapeutic activity nor active markers are generally known. Therefore, these herbal
substances are essentially defined by their production process and their specifications. For
other herbal substances, the name and content of the analytical marker(s) should not be
stated. The quantity of genuine herbal substance should be given.
{d) Declaration of herbal preparations in the Summary of Product Characteristics
(SmPC): The declaration of herbal preparation should cover the name of the herbal
substance and the definition of the herbal preparation including; the physical state, ratio of
herbal substance to genuine herbal preparation and extraction of solvent(s). The name of the
herbal substance is the scientific Latin name of the plant species according to the binomial
system (genus, species, variety and author) with the Latin term of the plant part, followed by
3.2
Quality Control and Standardization of Herbals EU and ICH Guidelines tor .....
• At the end of the study, the survivors should be autopsied immediately, the organs
and tissues of all animals in each group should be examined macroscopically. The
histopathological examination should be performed on all animals in the highest
dose group and the control group.
Evaluation of result<: A test substance is considered to be positive for
carcinogenicity when any of the following types of response has been observed in
the carcinogenicity study:
o Development of tumours of a type not seen in the control group.
o Development of tumours seen with greater frequency in the test group,
compared with the control group.
o Greater varieties of organs and tissues are involved in tumour d'evelopment in the
test groUJp, compared with the control group.
o Earlier development of tumours in the test group, though in the absence of any
significant difference in the incidence of tumours between the test group and the
control group.
3.70
Quality Control and Standardization of Herbals EU and ICH Guidelines tor .....
3.71
3.72
