The document provides guidelines for regulating herbal medicines in Europe and Japan. In Europe, herbal medicinal products are regulated and must comply with guidelines on quality control, safety, efficacy, advertising and more. Herbal medicines from foreign countries entering the market must also provide proof of quality, safety and efficacy. In Japan, traditional herbal medicines called Kampo are regulated similarly to conventional drugs, and must undergo clinical trials and comply with good manufacturing practices. Japan also has various systems for monitoring adverse reactions to herbal medicines. The regulatory frameworks aim to standardize quality while allowing traditional herbal approaches to be practiced legally.

1. Guidelines for the regulation of
herbal medicines
Europe
Union

2. Guidelines for the regulation
Of herbal medicines
Europe Union
Post-
marketing
surveillance
Products
from
foreign
countries
Combination
products
Individual
supply
Further
developed
products
ESCOP
& WHO
monographs
GMP &
Quality
control
Advertising,
distribution
& retail sale
Classification
Documentation
of quality,
safety
& efficacy
Simplified
proof
of efficacyThe
regulation of
Functional
Foods
&
Nutraceuticals
Definition
Differences
between
Member
States
Guideline ‘Quality of Herbal Medicinal
Products’ includes plants, parts of plants &
their preparations, mostly presented with
therapeutic or prophylactic claims

5. 7- The regulation of
Functional Foods
& Nutraceuticals
Packaging
Nutrition labeling
Labelling
Food Labelling
8- Individual
supply
Herbal medicinal products are made
up and/or supplied to individual patients
following a 1-1consultation between
patient and practitioner.
A specific situation exists in the United Kingdom,
where a practitioner, according
to Section 12 of the Medicines Act 1968
may supply products to a
customer without a licence.
9- Products from
foreign countries
Control of raw
materials or crude drugs, particularly
for products that enter the market as
foodstuffs or other products that are
not controlled in the same way as
Medicinal products
Finished products are often treated as new
chemical entities with full proof of
quality, safety and efficacy being required.

6. 10- GMP &
Quality
control
11- Post-marketing
surveillance
12- Advertising,
distribution
& retail sale
13-Differences
between
Member
States
European Pharmacopoeia in
all Member States 1964
natural state after desiccation or
concentration or for the isolation
of natural
active ingredients
The adverse reaction reporting
Systems case of several
withdrawals of marketing authorizations
for herbal medicinal products due to
safety concern in connection with
certain plants
Council Directive 92/28/EEC on advertising in
national law
Wholesale marketing of all medicinal
products as
well as authorized herbal
medicinal products is covered by
Council Directive 92/25/EEC
different traditions regarding the
therapeutic use of
medicinal plant preparations,
which may
make it more difficult for manufacturers
of herbal medicinal products to apply for
marketing authorization using the
decentralized procedure

7. Guidelines for the regulation of
herbal medicines
Japan

8. Introduction
Japanese traditional medicine, as used in
Japanese society for 1000+++ years
146 Kampo drugs are registered as drugs
by the Ministry of Health and Welfare
(MHW) and are included in coverage
under the National Health Insurance.
Each Kampo drug is a formula usually
consisting of 5-10 different herbs
Local traditional usage is not sufficient for
approval as a drug; the claims and rules of
combinations of herbal ingredients are
determined on the basis of the
pharmacological actions of the
ingredients.
If a monograph is not available, the claims
reported in the Japanese Pharmacopoeia
are used as a guide.

9. Introduction
The same data required for new ‘western’ drugs are
required for new Kampo drugs, including data from
three-phase clinical trials.
1986 GMP Law, the standard applied to all
pharmaceutical drugs has also applied to Kampo
drugs.
1985, guidelines for ethical extract products in oriental
medicine formulations were developed
The MHW has three major systems for collection of
adverse reaction data.
1st
- is a voluntary system involving 2915 monitoring
hospitals.
2nd
- system — the Pharmacy Monitoring System —
which includes 2733pharmacies, collects data on
cases.
3rd
- system is Adverse Reaction Reporting from
Manufacturers.

10. Regulatory situationRegulatory situationRegulatory situationRegulatory situation
They are regarded as a form of combined drug, and the
same data required for new Western drugs are
required for new Kampo drugs in the NDA.
The time-consuming and expensive chronic toxicity
tests and special toxicity tests such as for
(a)Mutagenicity,
(b) carcinogenicity and
(c) teratogenicity
Data for 3 phase clinical trials are also required
For generic Kampo drugs, bioequivalence data are
required, which may discourage development,
because pharmacokinetic studies of Kampo drugs
are difficult to conduct and bioassay methods are
quite limited.
When using substances listed in Japanese Standards
for Herbal Medicines as materials or ingredients of
pharmaceutical products to be manufactured
/imported into, Japan -should comply

11. Regulatory situationRegulatory situationRegulatory situationRegulatory situation
Regulations for Manufacturing Control
and Quality Control of Drugs effect in
April 1996.
The Japan Pharmacists Education Centre
(243) issues a certificate for pharmacists
specializing in kampo medicines and
herbal materials in accordance with its
own qualification criteria.
Renewal of this certification is required
every 3 years.
This system requires all registered
specialists to attend authorized meetings
of the Society and to present relevant
scientific papers and medical journals
at the meetings.
This registration system requires
registration as a specialist in kampo
medicine to be renewed every 5 years,