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  • General Information

According to Drug Act B.E. 2510 (1967)1, drugs are classified into two major groups; namely, Modern drugs and Traditional drugs.  “Traditional drug” was defined as a drug intended for use in the practice of the traditional medicine or the cure of an animal disease which appears in a pharmacopoeia of traditional drug notified by the Minister, or a drug notified by the Minister as a traditional drug, or a drug of which formula has been registered as that of a traditional drug.

Types of registered herbal medicines
Thai FDA classified herbal medicinal products into four categories, namely: -

  1. Traditional drugs.  These are Thai traditional medicines or traditional Chinese medicine of which the indication, therapeutic claims, dosage and administration are based on traditional knowledge that have been passed on from generation to generation or from traditional textbooks recognized by the ministerial regulation.  The dosage forms of traditional drugs are not different from traditional dosage forms.
  2. Modified traditional drugs.  These are traditional medicines of which the indication, therapeutic claims, dosage and administration are based on traditional knowledge as in the first group but the dosage forms have been modified into modern dosage forms, e.g. capsules or tablets, for the ease of use and an increased compliance.
  3. Modern herbal medicines or Phytopharmaceuticals.  These are herbal medicinal products that are composed of active plant materials in the form of semi-purified compounds derived from scientific research and are classified as modern medicines.  The indication, therapeutic claims, dosage and administration of herbal drugs are usually based on clinical trial evidence.  This group of drugs is usually made of standardized herbal extracts prepared into various modern dosage forms.
  4. New drugs.  These are new drugs from herbs developed through complete drug development process and are in the form of purified isolated active substances of which the chemical structures were identified as new chemical entities; hence, this group of drugs is classified as modern medicines.

According to this classification, most of Thai traditional medicines and herbal medicines available in the market in Thailand fall into the first three categories of herbal medicinal products.

The registration of traditional medicinal products, the licensing of traditional medicine manufacturers, and post-marketing surveillance are the responsibility of Thai Food and Drug Administration (FDA), Ministry of Public Health.  Herbal medicines that are prepared from single or several herbal materials into different dosage forms have to be registered with the FDA prior to manufacturing and selling.  Medicinal plant materials or crude drugs are exempt from registration in order to make it easy for the public to use herbs for health care.  Prior to the production of any traditional medicine, the manufacturers must apply for manufacturing license from the FDA and have their manufacturing facilities well prepared and well equipped for the inspection by the FDA.  Licensed manufacturers can then file for the registration of their traditional medicines prior to the production.  The information submitted by the manufacturers for the registration of traditional medicines will then be considered by the subcommittees appointed by the Drug Committee. 

Similarly, the importers of traditional medicines must apply for import license from the FDA first.  Licensed importers can then file for the registration of the traditional medicines that they would like to import into Thailand.

Duration of registration of traditional medicines is about 160 working days

In addition to drug samples, the following information is required for the registration of traditional medicines: -

  • The appearance and color of the product
  • The name of the product
  • Packaging size & type of container
  • Label containing required information, e.g. name, registration number, content, Lot No., manufacturing date, manufacturer, city & country, importer, etc.
  • Package insert
  • Drug recipe indicating the ingredients and amount in metric unit or as percentage in the recipe.  Specifications are needed for other pharmaceutical necessities, preservatives, flavoring agents added.
  • Manufacturing process
  • Manufacturer or importer and license number and signature

For imported products, the following documents are also needed: -

  • Certificate of Free Sale issued by national authority
  • Official document from national authority to certify that the manufacturing plant is certified or permitted to produce the product.

The Drug Act of B.E. 2510 (1967) is currently stilled in effect.  Attempts to revise the Drug Act have been painstaking and time-consuming; when it becomes effective, many features will be changed.

New regulation on the production, sale, or import of traditional medicines according to ASEAN harmonization of regulations and standards of traditional medicines

To comply with ASEAN harmonization of rules and regulations on product registration, production standards, and quality control of traditional medicinal products, Thai FDA recently issued Ministry of Public Health Regulation on Submission for License and the Issuance of License for the Production, Sale, or Import of Traditional Medicines into the Kingdom B.E. 2555 (2012) that was published in the Royal Gazette on 4 July 2012.  This Ministerial Regulation indicated in Item 7 that licensed manufacturers of traditional medicines shall produce medicines that meet the quality standards specified by the Minister of Public Health and shall manufacture using GMP of traditional medicines specified by the Minister of Public Health that will be published in the Royal Gazette.  To enforce the above-mentioned Ministerial Regulation, Ministerial Notification on GMP of Traditional Medicines is currently under consideration and formulation.  Before the Ministerial Notification will be issued, manufacturers are required to follow the GMP guideline 2005.

  • Contact Details

Bureau of Drug
Food and Drug Administration
Ministry of Public Health
Tiwanont Road, Muang, Nonthaburi
Thailand 11000
Tel: + 662 590 7162, +662 590 7163-4
Fax: +662 590 7164
Website: http://drug.fda.moph.go.th/eng/

Reference:

  1. Drug Act B.E. 2510 (1967). [cited 2012 Oct 6]. Available from: http://thailaws.com/law/t_laws/tlaw0071_1.pdf

 

National Health Commission

National Health Commission Office of Thailand

National Health Building, 3rd Floor,

88/39, Tiwanont 14 Rd., Muang District,

Nonthaburi 11000 Thailand.

Tel: +66-2832-9000

Website: http://en.nationalhealth.or.th/