A. Traditional Knowledge Drugs

         Traditional knowledge drugs are herbal drugs derived from traditional knowledge intended for the therapy, treatment and alleviation of human illnesses or the prevention of diseases, and consist of traditional knowledge drugs based on Thai or Chinese traditional medical textbooks and drugs produced according to the practice of Thai or Chinese traditional medicine where the mixing, compounding or processing of herbs are done in accordance with a traditional knowledge which provides sufficient and reliable data regarding their safety and efficacy, without the need for additional safety or efficacy study.

         Traditional knowledge drugs can be divided into 2 types:

(1)    Thai traditional drugs mean drugs obtained directly from herbs or derived from the mixing, compounding or processing of herbs which are intended to be used in accordance with Thai traditional medicine knowledge, or herbal drugs prescribed in a Notification by the Minister as Thai traditional drugs, including herbal drugs published in nationally recognized medical textbooks and drug formulae formulated according to Thai traditional medicine knowledge.

(2)   Chinese traditional drugs mean drugs obtained directly from herbs or derived from the mixing, compounding or processing of herbs which are intended to be used in accordance with Chinese traditional medicine knowledge, or herbal drugs prescribed in a Notification by the Minister as Chinese traditional drugs, including herbal drugs published in nationally recognized medical textbooks and drug formulae formulated according to Chinese traditional medicine knowledge.

B. Developed Herbal Drugs

         Developed herbal drugs are drugs obtained directly from herbs or derived from the mixing, compounding or processing of herbs, which are not Thai traditional drugs or drugs derived from the knowledge of alternative medicine prescribed in a Notification by the Minister upon the recommendation of the Committee, and which are used for the therapy, treatment and alleviation of human illnesses or the prevention of diseases. In other words, they are herbal drugs developed from traditional knowledge, well-established herbal drugs, or drugs derived from new herbs, which require scientific evidence to support their quality, safety and efficacy, as the case may be.

         Developed herbal drugs can be divided into 4 types:

(1)    Modified formulations mean herbal drugs of which the production processes are developed differently from the processes under the traditional knowledge in terms of their dosage forms, apart from the herbal drugs formulated according to Thai or Chinese traditional medicine knowledge, and of which active ingredients, strength, dosage, release characteristics, and properties are in line with traditional formulae.

(2)   Well-established herbal medicines mean herbal drugs which are sufficiently supported by bibliographical evidence and have well-established medicinal use and such evidence is recognized by a drug regulatory agency, or drugs which are established in the National List of Essential Herbal Drugs, or drugs within the monographs approved by the Food and Drug Administration with the recommendation of the Herbal Products Committee. The application for the registration of such herbal drugs must have undergone the recommendation process of the Food and Drug Administration on a case-by-case basis.

(3)   Scientifically established herbal medicines mean herbal drugs or drugs derived from the knowledge of other alternative medicine apart from those prescribed in a Notification, which require support from scientific data, such as non-clinical trial, clinical trial, data from academic journals, together with data from the cumulative body of transgenerational knowledge.

(4)   Herbal medicines derived from new herbs mean herbal drugs which are derived from a new type of herb with no usage according to traditional knowledge and require support from scientific data, such as non-clinical trial, clinical trial, and data from academic journals.

C. Herbal health supplements                             

         Herbal health supplements are products made from herbs or products of which an active ingredients is herbs or processed from herbs which are ready to be used in human beings to improve their health or the function of their bodies, strengthen the structure or the function of human bodies or reduce the risk factors of a disease, except herbal products used for the therapy, treatment and alleviation of human illnesses or the prevention of diseases.

         Herbal health supplements can be divided into 4 types:

(1)  Herbal health supplements according to traditional knowledge mean herbal health supplements which have been historically used in accordance with Thai or Chinese traditional knowledge, having:

1.1     formulae, composition, and active ingredients in accordance with traditional knowledge;

1.2     purposes of use that can be referred back to traditional knowledge;

1.3     strength and dosage in accordance with traditional knowledge;

1.4    routes of administration in accordance with traditional knowledge.

(2)   Developed herbal health supplements mean herbal health supplements which have been historically used in accordance with Thai or Chinese traditional knowledge, but of which the production processes are developed differently from the processes under the traditional knowledge in terms of their dosage forms, apart from the herbal health supplements formulated according to Thai or Chinese traditional medicine knowledge, and of which active ingredients, strength, dosage, release characteristics, and health benefit claims are in line with traditional formulae, having:

2.1     formulae, composition, and active ingredients in accordance with traditional knowledge;

2.2    purposes of use that can be referred back to traditional knowledge or comparable to those of traditional knowledge;

2.3    strength and dosage in accordance with traditional knowledge or comparable to those of traditional knowledge;

2.4    routes of administration in accordance with traditional knowledge or comparable to those of traditional knowledge.

(3)  Herbal health supplements with scientific reference mean herbal health supplements which require scientific document or evidence to support their quality, safety and efficacy, as the case may be, which can be divided into 2 types:

3.1     products consisting of herbs or other active ingredients which have been used for at least 15 years;

3.2    products consisting of herbs or other active ingredients which have been used for less than 15 years.

(4) Herbal cosmeceuticals mean products made from herbs which are intended to be placed in contact (by applying to, massaging or rubbing into, sprinkling or spraying on, dropping onto, introducing into, perfuming, or by any other means,) with various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, to improve their health or the function of their bodies, strengthen the function and condition of human bodies. Examples of these products are:

1)      hair growth products or anti-hair loss products, except for products which claim to be “anti-hair loss products” or claim to “reduce hair loss” after using the products that makes the hair soft, smooth and not tangled;

2)     dental products, except for toothpastes, mouthwashes, breath fresheners, and teeth whitening products which have a property of cavity prevention, teeth strengthening or breath freshening;

3)     products which soothe itchy scalp, except for oil-control shampoos which soothe itchiness;

4)     mole-removing products and melasma-removing products;

5)     anti-melasma products, anti-freckle products and whitening products, except for brightening products which make darkened skin appear brighter;

6)     anti-sunburn products, except for after sun products;

7)     acne treatment or anti-acne products, except for facial oil control products which aim to prevent acne;

8)     products which prevent cracked skin or which smoothen the skin, except for those that prevent cracked skin by moisturizing the skin or smoothen the skin’s physical appearance;

9)     skin brightening products which prevent the generation of melanin;

10)   skin brightening products which accelerate the degeneration of melanin;

11)     anti-wrinkle products, except for products which reduce wrinkles by moisturizing the skin;

12)    products which reduce skin irritation as a result of atopic prone skin;

13)    products which reduce stretch marks, except for products which prevent stretch marks by moisturizing the skin.

Herbal products can be categorized into 2 categories as follows:

1)  High-risk product category means herbal products with an indication to use for the therapy, treatment and alleviation of, or the prevention of, diseases as follows:

1.1     products for the therapy, treatment and alleviation of, or the prevention of, serious forms of illnesses or diseases;

1.2     products which could be misused;

1.3     products which require special use control for consumer safety;

1.4    products which are sterile injections or products for human eyes;

1.5     products of which the dosage form and method of application are complicated or difficult to administer into the body;

1.6    products which may cause serious adverse effects or require strong safety control.

Serious forms of illness or disease mean symptoms, diseases or illnesses of which the diagnosis or treatment requires a qualified healthcare professional or is beyond the ability of a consumer to self-treat or correctly self-diagnose without regular consultation with a qualified healthcare professional, e.g., alcoholism, anxiety state, infectious respiratory syndromes, psychotic conditions, inflammatory and debilitating arthritis, addiction (except for nicotine addiction), arteriosclerosis, asthma, cancer, congestive heart failure, convulsions, dementia, depression, diabetes, gangrene, glaucoma, haematologic bleeding disorders, hepatitis, hypertension, nausea and vomiting of pregnancy, obesity, rheumatic fever, septicaemia, sexually transmitted diseases, strangulated hernia, thrombotic and embolic disorders, thyroid disease, ulcer of the gastro-intestinal tract.

2) Non-high risk product category means products which are not high-risk products, including products with low risks and wide safety margins, having indications, purposes of use, properties, or health benefit claims which are related to the strengthening of health, health enrichment, prevention of malnourishment, reduction of the risks of diseases, as well as the therapy, alleviation or treatment or the prevention of unusual symptoms or non-serious forms of illnesses or diseases.

Non-serious forms of illness or disease mean symptoms, diseases or illnesses apart from those of serious forms of illnesses or diseases and include symptoms, diseases or illnesses that can naturally resolve on their own after a certain period of time, or if left untreated, can be expected to improve, but not as much as if treated with a product.

For more information, please refer to the Guidelines on Preparation of Documents for Herbal Products Application.