Guidelines for the regulation of herbal medicines

Europe

Union

Guidelines for the regulation Of herbal medicines

Europe Union

Post-marketingsurveillance

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

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 betweenpatient and practitioner.

A specific situation exists in the United Kingdom, where a practitioner, accordingto Section 12 of the Medicines Act 1968may supply products to acustomer without a licence.

9- Products from foreign countries

Control of rawmaterials or crude drugs, particularly for products that enter the market asfoodstuffs 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 ofquality, safety and efficacy being required.

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 naturalactive ingredients

The adverse reaction reporting Systems case of several

withdrawals of marketing authorizations for herbal medicinal products due tosafety 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 herbalmedicinal 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 manufacturersof herbal medicinal products to apply for

marketing authorization using thedecentralized procedure

Guidelines for the regulation of herbal medicines

Japan

IntroductionJapanese 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.

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.

Regulatory situationRegulatory situationRegulatory situationRegulatory situationThey 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

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,