Herbal Medicines

Laws, Standards and Regulations

Omega, Jan Laurence

Pueblo, Beverly Jane
Herbal medicines

• Herbal medicines are also referred to as herbal remedies, herbal products,

herbal medicinal products, phytomedicines, phytotherapeutic agents and
phytopharmaceuticals.
• Plants have been used medicinally for thousands of years by cultures all over
the world. According to the World Health Organization (WHO), 80% of the
world's population uses plant-based remedies as their primary form of
healthcare.
• It is estimated that the world market for herbal medicines and herbal products
is worth US$ 62 billion and would hit US$ 5 trillion by 2050. The market is
growing at 7% per annum.
WHO GUIDELINES
 WHO GUIDELINES
WHO Guidelines Major resolutions taken Year
Quality control methods for medicinal plant Emphasized the need to ensure the quality of medicinal plant products by using modern
1998
materials control techniques and include suitable standards and limits for contaminants are included.

WHO guidelines on safety monitoring of

Provide technical guidance on the principles of good pharmacovigilance and the inclusion
herbal medicines in pharmacovigilance 2004
of herbal medicines in existing national drug safety monitoring systems.
systems
This guideline aims to facilitate the registration and regulation of herbal medicines by
Guidelines for the Regulation of Herbal
establishing the foundation for a harmonized regulatory standard to meet the common 2003
Medicines in the South-East Asia Region
demands of the region.
Harmonize the use of certain accepted and important terms in TM, summarize key issues
General Guidelines for Methodologies on
for developing methodologies for research and evaluation of TM, improve the quality and
Research and Evaluation of Traditional 2000
value of research in TM, and provide appropriate evaluation methods to facilitate the
Medicine
regulation and registration of TMs.

National policy on TM and regulation of herbal Main objectives of this report are framing policy for safety, efficacy, and quality of herbal
2005
medicines Report of a WHO global survey medicines and its promoting rational use.
Quality assurance of medicinal plant materials used as the source for herbal medicines, and
WHO guidelines on good agricultural and
encourage and support the sustainable cultivation and collection of medicinal plants of 2003
collection practices for medicinal plants
good quality.
“A few herbal medicines have withstood scientific testing, but others are used simply for traditional reasons to protect, restore, or improve health.”
 REGULATIONS IN
DIFFERENT COUNTRIES
 Herbal Drug Regulation
in different countries
Country Legal status/policy Major responsibilities Year

Therapeutic Goods Act The overall objective of the Act is to ensure the quality, safety, and efficacy of therapeutic
Australia 1989
(Commonwealth of Australia, 2001a) goods, including medicines and medical devices available to the Australian public.

Ensure that the herbal medicinal plant product is safe under the recommended conditions
Canada Natural Health Products Regulations 2004
of use without a prescription, effective for the proposed claims, and of high quality.

The Drug Administration Law of the Encourages the development of both modern and traditional drugs, protects the resources
China 1984
People’s Republic of China of wild herbal drugs, and promotes domestic cultivation of herbal drugs.
Herbal finished drugs have to comply with the same criteria for quality, safety, and effi
Germany Medicines Act of 24 August 1976 1976
cacy as all other fi nished drugs
Law on Public Health, Chapter IV, Herbal drugs regulated as over the counter medicines for selfmedication purposes and by
Hungary 1996
Section 104 law, medical claims, and health claims may be made.
Production, distribution and labeling of traditional drugs, and licensing of traditional drugs
Indonesia Directorate of Traditional Drug Control 1975
and imported traditional drugs
The Ministry of Public Health and
Korea Regulate and rule on the herbal medicines and their preparations. 1969
Social Affairs
The Spanish Medicinal Products Act Objective of the Act is to ensure the quality, safety, and efficacy of therapeutic goods,
Spain 1990
No. 25 including herbal medicines.
Medicines and Healthcare products
Licensed medicinal products require evidence of quality, safety, and efficacy and are
United Kingdom Regulatory Agency (MHRA) and 1968
regulated by the Medicines Control Agency.
Medicines Act 1968
EU Regulations
Herbal medicines in EU

• A new EU Directive on Traditional Herbal Medicinal Products 2004/24/EC came

into force in April 2004 requiring Member States to implement registration
schemes by October 2005.
• The aim is to remove the differences which create obstacles to the free
movement of medicinal products in the EU, while ensuring protection for public
health.
• In almost all Member States, herbal medicinal products are considered as
medicinal products and are, in principle, subject to the general regulations for
medicines as laid down in the various national medicine laws. In many cases, a
specific definition of herbal medicinal products is available, which is in line with
the EU Guideline “Quality of Herbal Medicinal Products.”
Medicines Act 1968
Herbal Medicines

European Community Council Directives and Regulations together with the

Medicines Act 1968 (from now on referred to as the Act) regulate the
manufacture, distribution and importation of :
(a) medicines for human use,
(b) medicines for administration to animals
(c) medicated animal feeding stuffs.
Medicines Act 1968
Herbal Medicines

• In March 2004, the European Community issued a Directive on Traditional

Herbal Medicinal Products (2004/24/EC), which amended Council Directive
2001/83/EC as far as herbals products were concerned.

• An Herbal Medicines Advisory Committee has been established (SI 2005 No.
2791) to give advice with respect to safety, quality and efficacy in relation to
human use of herbal medicinal products.
Medicines Act 1968
Herbal Medicines

A traditional herbal medicinal product means an herbal medicinal product that fulfils the conditions
laid down in Article 16a(1) of Directive 2004/27EC. The conditions laid down are that a simplified
registration procedure is established for the product which fulfils the following criteria. The product:
• has indications exclusively appropriate to traditional herbal medicinal products which, by virtue of its
composition and purpose, is intended and designed for use without the supervision of a medical
practitioner for diagnostic purposes or for prescription or monitoring of treatment;
• is exclusively for administration in accordance with a specified strength and posology;
• is an oral, external and/or an inhalation preparation;
• has a period of traditional use which has elapsed; the period of traditional use is 30 years, including
15 years within the European Community, preceding the date of application for registration;
• has data on the traditional use sufficient to prove that the product is not harmful in the specified
conditions of use and the pharmacological effects or efficacy of the product are plausible on the
basis of long-standing use and experience.
Philippine Regulations
REPUBLIC ACT NO. 8423

Traditional and Alternative Medicine Act (TAMA) of 1997

Objectives
• (a) To encourage scientific research on and develop traditional and alternative health care systems that have direct impact on public health care;
• (b) To promote and advocate the use of traditional, alternative, preventive and curative health care modalities that have been proven safe,
effective, cost effective and consistent with government standards on medical practice;
• (c) To develop and coordinate skills training courses for various forms of traditional and alternative health care modalities;
• (d) To formulate standards, guidelines and codes of ethical practice appropriate for the practice of traditional and alternative health care as well as
in the manufacture, quality control and marketing of different traditional and alternative health care materials, natural and organic products, for
approval and adoption by the appropriate government agencies;
• (e) To formulate policies for the protection of indigenous and natural health resources and technology from unwarranted exploitation, for approval
and adoption by the appropriate government agencies;
• (f) To formulate policies to strengthen the role of traditional and alternative health care delivery system; and
• (g) To promote traditional and alternative health care in international and national conventions, seminars and meetings in coordination with the
Department of Tourism, Duty Free Philippines, Incorporated, Philippine Convention and Visitors Corporation and other tourism-related agencies as
well as non-government organizations and local government units.
REPUBLIC ACT NO. 8423

Traditional and Alternative Medicine Act (TAMA) of 1997

• Establishment of the Philippine Institute of Traditional and Alternative Health Care (Article III, Section 5)
• Promotion of traditional and alternative health care (Article IV).
• The Institute, in collaboration with the Bureau of Food and Drugs, shall formulate standards and
guidelines for the manufacture, quality control and marketing of different traditional and alternative
health care materials and products (Section 13).
• Incentives for the Manufacturers of Traditional and Alternative Health Care Products (Section 14)