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GENERAL INFORMATION

NAME               : Dr. Win Htay Aung

DESIGNATION : Director General Department of Traditional Medicine

CONTACT NO   : +95-9-260607030, +95-9-36031611, +95-9-49326769

FAX NO             : 067-431091

EMAIL               :  This email address is being protected from spambots. You need JavaScript enabled to view it.

 

GENERAL INFORMATION

NAME : Mr. Win Myint

DESIGNATION : Director ( Research and Development)

CONTACT NO :95949207898

FAX : 95 266104

EMAILThis email address is being protected from spambots. You need JavaScript enabled to view it.

GENERAL INFORMATION

NAME                : Fabian M. Dayrit

DESIGNATION : Professor, Department of Chemistry and

                      Dean, School of Science and Engineering (SOSE), Ateneo de Manila University Loyola

                      Heights, Quezon City, Philippines

ADDRESS         : School of Science and Engineering, Ateneo de Manila University, Katipunan Ave., Loyola

                           Heights, Quezon City, Philippines 1108(OFFICE)

CONTACT NO   :(632) - 426-6001 (OFFICE)

EMAIL               :  This email address is being protected from spambots. You need JavaScript enabled to view it. ,

                            This email address is being protected from spambots. You need JavaScript enabled to view it.

 

DETAIL INFORMATION

GENERAL INFORMATION

NAME                : Dr. Alvin Lee

DESIGNATION  : Assistant Director (Primary Care/Traditional & Complementary Medicine),

                            Ministry of Health, Singapore

ADDRESS         : Ministry of Health, 16 College Rd, College of Medicine Building, 

                            Singapore 169854

CONTACT NO   : +65 63251009

EMAIL               : This email address is being protected from spambots. You need JavaScript enabled to view it.

DETAIL INFORMATION

GENERAL INFORMATION

NAME                 :   Cheng Libota

DESIGNATION  : Technical Officer

CONTACT NO    : +855 12811005

EMAIL               : This email address is being protected from spambots. You need JavaScript enabled to view it.

GENERAL INFORMATION

NAME : Assoc Prof Dr. Konmany Sydara

DESIGNATION : Director of Institute of Traditional Medicine

CONTACT NO : +856 2131 5693

FAX : +856 2131 5693

EMAIL :This email address is being protected from spambots. You need JavaScript enabled to view it.

  • General Information

Under the Practice of the Art of Healing Act; B.E. 2542 (1999), the Ministry of Public Health officially recognizes 3 types of TM/CAM as branches of “the Art of Healing”; namely, Thai traditional medicine (TTM)10, traditional Chinese medicine (TCM)2, and chiropractic2

According to the Act, the art of practice of TTM can be divided into 2 categories; i.e., Thai traditional medicine and applied Thai traditional medicine.  The ‘Profession Commission in the branch of Thai traditional medicine’ and the ‘Profession Commission in the branch of applied Thai traditional medicine’ are responsible for the registration and issuing or revoking the license of TTM and applied TTM practitioners, respectively.1 The Bureau of Sanatorium and Art of Healing, Department of Medical Service Support, Ministry of Public Health serves as the secretariat office of the two profession commissions.  In addition, the commissions are also responsible for the control of professional practice by setting up the standards and code of professional practice, reviewing and approving the teaching curricula of academic institutions, and considering professional misconduct of practitioners and appropriate measure of punishment.1  In order to become a licensed practitioner, a person must take a licensing examination given by the commissions in the branch that he/she was trained for.  Similarly, there are also Profession Commissions in the branch of TCM and chiropractic that have the same responsibilities in their branch of practice.  Therefore, any person who would like to practice any of the three branches of TM/CAM recognized by the Practice of the Art of Healing Act; B.E. 2542 (1999); namely, TTM, TCM or chiropractic must be registered with respective profession commission and pass licensing examination offered by the profession commission to become a licensed practitioner before he/she can legally practice.1

Licensing of TTM and applied TTM practitioners

As previously mentioned, according to the Practice of the Art of Healing Act B.E. 2542 (1999), the art of practice of TTM can be divided into 2 categories; i.e., Thai traditional medicine and applied Thai traditional medicine.  In order to become a licensed applied TTM practitioner, a person with Bachelor’s degree in applied Thai traditional medicine must pass a licensing examination that cover all areas of TTM; namely, Thai traditional medicine, Thai traditional pharmacy, Thai traditional midwifery and Thai traditional massage (Nuad Thai).  Licensed applied TTM practitioners will be able to practice all areas of TTM under one license.  In contrast, in order to become a licensed TTM practitioner, a person who is qualified to take a TTM licensing examination (completed apprenticeship training or received degree or certificate from certified academic institution) needs to pass separate licensing examination for each filed of TTM practice to obtain separate licenses to practice in each of the four fields of TTM.1

According to Article 33(1) of the Practice of the Art of Healing Act, in addition to the requirement to pass licensing examination to become a licensed practitioner, there is another procedure that a person with a long practical experience in Thai folk massage can be registered and licensed as a TTM practitioner; namely, by being certified by a government office and passing the evaluation process under the conditions set by the Profession Commission in the branch of Thai Traditional Medicine.1  This system of licensing is based on two Notifications of the Profession Commission in the branch of TTM issued on July 13, 20044,5 involving

  1. The evaluation of a person whom a government office certified as one with experience in Thai indigenous medicine for the registration and licensing as a Thai traditional medicine practitioner in the field of Thai traditional medicine4; and
  2. The evaluation of a person whom a government office certified as one with experience in Thai massage for the registration and licensing as a Thai traditional medicine practitioner in the field of Thai massage5

These Notifications gives folk healers who have never has a license for the practice of Thai traditional medicine but have long experience and knowledge in Thai indigenous medicine (folk medicine) or folk massage and have used their experienced knowledge of Thai indigenous medicine or folk massage to treat various symptoms or diseases of people in their communities for many years an opportunity to be registered and licensed as TTM practitioners in the field of Thai traditional medicine or Thai traditional massage after passing the evaluation by the Profession Commission.4,5

The Notification of the Profession Commission in the branch of Thai traditional medicine specifies the qualifications of a person who has the right to be nominated as one with experience in Thai indigenous medicine or Thai massage as follows4,5

  • Has Thai nationality
  • Resides in Thailand
  • Has experience in Thai indigenous medicine for not less than 20 years
  • (For experience in Thai massage) Has one of the following qualifications or experiences: -
    • is a TTM practitioner in the field of TTM with experience in Thai massage for not less than 12 years, is a teacher of Thai massage for not less than 7 years and is at least 32 years of age, or
    • is one with experience in Thai massage for not less than 14 years, is a teacher of Thai massage for not less than 9 years, and is at least 37 years of age, or
    • is one with experience in Thai massage for at least 20 years.
  • Does not have forbidden characteristics described in the Article 32(3)-(7) of the Practice of the Art of Healing Act B.E. 2542.Table 6 shows the number of licensed TTM and applied TTM practitioners as of 20 September 2011.

In pursuance of the above-mentioned notifications, the guideline for the screening and evaluation of folk healers, qualifications of folk healers, and criteria for the evaluation were set up.  The information required for the evaluation of a folk healer is divided into three parts; namely, 1) personal history including how one obtain or gain knowledge on folk medicine and his/her area of expertise; attitude, belief, and conduct as a folk healer; 2) case studies of patients who received treatments by the folk healer (qualitative study in at least 10 cases & quantitative study); and 3) study on the acceptance of the folk healer by his/her community.6

The first group of licensed TTM practitioners in the field of Thai massage (81 people) was issued the license by this method on 29 September 2005.  As of October 2012, there have been 161 folk healers who passed the evaluation by TTM Profession Commission and became licensed TTM practitioners in the field of Thai traditional medicine.

Table 6 shows the number of licensed TTM and applied TTM practitioners as of 20 September 2011.7

Table 6: Number of licensed TTM and applied TTM practitioners as of September 2011.16

Types of practitioners

Cumulative number of licensed practitioners

Fiscal year 2011

(Oct 10-Sept 11)

New

Total

1. Thai traditional medicine

49,038

5,159

54,197

1.1 Thai traditional medicine

17,779

1,184

18,963

1.2 Thai traditional pharmacy

23,951

2,105

26,056

1.3 Thai traditional midwifery

6,780

493

7,273

1.4 Thai traditional massage

528

1,377

1,905

2. Applied Thai traditional medicine

826

396

1,222

Source: Bureau of Sanatorium and Art of Healing, Department of Health Service Support. Statistics of practitioners of the art of healing, fiscal year 2011 (as of 20 September 2011).

Draft Thai Traditional Medicine Profession Act
During the past three years, attempt has been made by civil society sector to draft and propose a new Act entitled “(Draft) Thai Traditional Medicine Profession Act (B.E…)” to the parliament.  This draft Act (along with two other versions of the draft Act proposed by the House of the Representatives) was considered, revised, and eventually passed by the House of the Representatives.  Currently, the draft Act is being considered by an Ad Hoc Committee of the House of the Senate and is expected to be considered and reviewed by the House of the Senate in late 2012.  It is estimated that the reviewed Act will finally be passed by the House of the Senate and the Act will be promulgated before the end of the year 2012.  After the Act becomes effective, there will be a major change on the regulation of the practice of Thai traditional medicine practitioners as they will become “Thai traditional medicine doctors” and the licensing and the regulation of the practice will no longer be under the authority of the two Profession Commissions but will be under the authority of the Thai Traditional Medical Council that will soon be established.

Licensing of traditional Chinese medicine practitioners
The Ministry of Public Health by Bureau of Sanatorium and Art of Healing, Department of Health Service Support is responsible for organizing TCM licensing examination once a year.  As of September 2011, the Ministry of Public Health has issued license for the practice of TCM to 388 qualified persons.  Among these, 309 are TCM doctors who learned TCM from their ancestors and lived in Thailand for more than 3 years, while 79 are TCM doctors who received Bachelor’s Degree in TCM from universities in Thailand or abroad.8
In addition, to TCM practitioners, modern medicine doctors or physicians who passed the three-month course on acupuncture certified by the Ministry of Public Health can also give acupuncture treatment for the patients in health service facilities.  As of September 2011, there were 1,004 physicians who completed this three-month training course on acupuncture.8

Licensing of the practitioners of chiropractic
Even though chiropractic is another branch of the art of healing recognized by the Ministry of Public health, it is not available in the public health service facilities.  The practice of chiropractic is available in private clinics or hospitals where the practice of chiropractic will be under the supervision of licensed physician(s) according to the Practice of the Art of Healing Act12.  As of 20 September 2011, there were only 19 licensed chiropractic practitioners in Thailand.7

  • Contact Details

Bureau of Sanatorium and Art of Healing
Department of Health Service Support
Ministry of Public Health
Tiwanont Road, Muang, Nonthaburi
Thailand 11000
Tel: +662 590 1331, +662 589 0757
Fax: +662 590 1332, +662 5901 8844 #303
Website: http://mrd-hss.moph.go.th/mrd/

Reference:

  1. Practice of the Art of Healing Act B.E. 2542 (1999). Thai Royal Gazette, Vol. 116 Pt. 39 A. 18 May 1999.
  2. Ministry of Public Health Notification (No.1) B.E. 2543 (2000) on “Permission of a person to practice the art of healing based on traditional Chinese medicine”. Thai Royal Gazette, Vol. 117 Pt. 71 D. 5 Sep 2000.
  3. Ministry of Public Health Notification B.E. 2549 (2006) on “Permission of a person to practice the art of healing based on the science of chiropractic”. Thai Royal Gazette, Vol. 123 Spec. Pt. 100 D. 28 Sep 2006.
  4. Notifications of the Profession Commission in the Branch of Thai Traditional Medicine on “Evaluation of a person whom a government office certified as one with experience in Thai indigenous medicine for the registration and licensing as a Thai traditional medicine practitioner in the field of Thai traditional medicine”.Issued on July 13, 2004.
  5. Notifications of the Profession Commission in the Branch of Thai Traditional Medicine on “Evaluation of a person whom a government office certified as one with experience in Thai massage for the registration and licensing as a Thai traditional medicine practitioner in the field of Thai massage”. Issued on July 13, 2004.
  6. Kulsomboon S, Ubolkhao P, et al. (eds.). Handbook on the evaluation of folk healers. 2nd ed. Bangkok: SamcharoenPanich. 2011.
  7. Bureau of Sanatorium and Art of Healing, Department of Health Service Support. Statistics of practitioners of the art of healing, fiscal year 2011 (as of 20 September 2011). [cited 2012 Oct 7]. Available from: 203.157.6.204/Admin/filestat/54.xlsx
  8. Techadamrongsin Y, Hazanine T, Jirapinijwong S (eds.).  Development of traditional Chinese medicine in Thailand. Bangkok: Union of Agriculture Cooperatives in Thailand Priniting.2554. 64 pages.

 

 

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/
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The information that follows should provide you with an overview of the laws on Trade Secrets/Confidential Information.
The information that follows should provide you with a basic overview of Geographical Indications.
The information that follows should provide you with a basic overview of Designs.
The information that follows should provide you with an overview of Trade Marks/Branding.
The information that follows should provide you with a basic overview of Copyright.
The information that follows should provide you with an overview of Plant Breeders Rights.
The information that follows should provide you with a basic overview of the Patent.
  • 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/
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Introduction and Overview


Industry Perspective

Current Trade Values On Import and Export Of Herbal Products For Malaysia


Product Registration

Processing of applications for product registrations is under the purview of the centre for product registration at the Drug Control Authority (DCA), Ministry of Health. The centre ensures that all registered pharmaceutical products are evaluated for their quality, safety and efficacy while all traditional medicine products and cosmetics are evaluated for safety and quality.


Government Incentives

In Malaysia, tax incentives, both direct and indirect, are provided for in the Promotion of Investments Act 1986, Income Tax Act 1967, Customs Act 1967, Sales Tax Act 1972, Excise Act 1976 and Free Zones Act 1990. These Acts cover investments in the manufacturing, agriculture, tourism (including hotel) and approved services sectors as well as R&D, training and environmental protection activities.

The direct tax incentives grant partial or total relief from income tax payment for a specified period, while indirect tax incentives come in the form of exemptions from import duty, sales tax and excise duty.

The following are the identified government incentives that are relevant to the traditional complementary medicine industry along its value chain of activities. (Source: MIDA)

trade-incentivesIncentives and Financial Assistance

Find the latest information on incentives and available financial assistance offered by institutions in Malaysia.

 

Market for Malaysian Natural Ingredients used in cosmetic, dietary supplement and pharmaceutical products


Josef A. Brinckmann
This email address is being protected from spambots. You need JavaScript enabled to view it.
June 2007

[important color=red title=Disclaimer]The designations employed and the presentation of material in this report do not imply the expression of any opinion whatsoever on the part of the "Global Information Hub on Integrated Medicine" concerning the legal status of any country, territory, city or area of its authorities, or concerning the delimitation of its frontiers or boundaries.[/important]
Citation: Brinckmann J. Market for Malaysian Natural Ingredients used in Cosmetic, Dietary Supplement and Pharmaceutical Products. "Global Information Hub on Integrated Medicine". www.globinmed.com. 2007

Product Description

This market survey covers natural ingredients that are used in the cosmetics, dietary supplement and/or pharmaceutical industries, respectively, with highlights on selected Malaysian medicinal and aromatic plants (MAPs), their extractives and oils, as classified under the Harmonized System (HS) codes listed in Table 1 on the following page.

Trade: Exports & Imports

Market Access Requirements

Price Information

Distribution Channels

Sales Promotion

APPENDICES

Therapy Definitions

The list below is a glossary to certain terms used to describe traditional and complementary medicine modalities that can be found in Malaysia and other parts of the world. This list is just the beginning and it is not exhaustive. It will be updated from time to time.

Note: These definitions are direct quotation from the source.

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