Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Close this folderHerbal medicines
View the documentCurrent status of traditional Chinese medicines in China
View the documentRegulation of traditional Chinese medicines in Hong Kong, China
View the documentProposed regulations for natural health products in Canada
View the documentHow regulation of herbal medicines was established in Thailand
View the documentHerbal medicine in the Islamic Republic of Iran
View the documentTraditional herbal medicines: an update on European Union activities
View the documentRegulation of herbal medicines in Ghana
View the documentRecommendations
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

How regulation of herbal medicines was established in Thailand

Ms Yupin Lawanprasert, Thailand

Herbal medicines play an important role in the everyday life of the Thai people. The use of herbal medicines has increased remarkably in line with the global trend of people returning to natural therapies. The Government and authorities concerned have taken part in the promotion and regulation of local herbal medicines in order to ensure that their quality, efficacy and safety meet international requirements and that they are used rationally. Manufacturers are also encouraged by the Government to improve their production standards to meet the requirements of Good Manufacturing Practices (GMP) and to conform to the higher specifications needed for the global market.

Under the Drug Act, herbal medicines are classified into four categories:

• herbal household remedies;
• traditional herbal medicines;
• modern herbal medicines;
• new drugs.


The Drug Act requires that any person who wishes to produce, sell or import drugs into Thailand must obtain a licence from the Food and Drug Administration (FDA) of Thailand. Herbal medicinal products must be registered before they can be produced or imported for marketing. An applicant must hold a manufacturing or importing licence granted by the FDA. The procedures for registration of herbal medicinal products are in two stages:

• application for permission to manufacture or import drug samples;
• application for drug registration.


Every application is evaluated by an expert subcommittee; if it is found that the product is proven to be safe and effective, it is registered.

Thailand has participated in the development of the ASEAN Guidelines on GMP for Herbal Medicines. GMP for herbal medicine is currently being implemented. It is recommended that herbal medicinal products should be manufactured in a GMP environment to ensure acceptable quality.

The main problem affecting the quality of traditional drugs is microbial contamination, since the use of synthetic preservatives is not permitted. Herbal medicinal products must therefore comply with the accepted limits for microbial stability specified in the Thai Pharmacopoeia.

Under the Drug Act, all materials used in the advertising and promotion of medicines, including herbal medicines, are subject to approval by the FDA of Thailand.

Thai traditional medicine is a valuable heritage of the Thai people. The Royal Thai Government has tried to revitalize its significance as an effective alternative treatment.

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