Date post: | 25-May-2015 |
Category: |
Health & Medicine |
Upload: | rabeah-lookyoung |
View: | 412 times |
Download: | 1 times |
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,