Full Title: WHO guidelines for assessing quality of herbal medicines with reference to contaminants and residues
Source: WHO Website
The objectives of these guidelines are to provide:
guiding principles for assessing the quality in relation to the safety of herbal
medicines, with specifi c reference to contaminants and residues;
model criteria for use in identifying possible contaminants and residues;
examples of methods and techniques; and
examples of practical technical procedures for controlling the quality of fi nished
herbal products.
In the pursuit of the above-mentioned objectives, these guidelines should be read
together with the other WHO documents and publications (including future
versions) relating to the quality assurance of herbal medicines with regard to
safety, for example (for details see reference list):
Quality control methods for medicinal plant materials (2)
Good agricultural and collection practices (GACP) for medicinal plants (3)
International pharmacopoeia, 4th ed. (4, 5)
WHO guidelines for assessing quality of herbal medicines with reference to contaminants and residues
Introduction
3
Good manufacturing practices: main principles for pharmaceutical products (6)
Good manufacturing practices: supplementary guidelines for the manufacture of herbal
medicinal products (7)
Guide to good storage practices for pharmaceuticals (8)
Good trade and distribution practices (GTDP) for pharmaceutical starting materials (9)
General guidelines for methodologies on research and evaluation of traditional
medicine (10)
Guidelines for assessment of herbal medicines (11)
WHO monographs on selected medicinal plants (12, 13
WHO guidelines for assessing quality of herbal medicines with reference to conta.pdf 1177 Kb
Source: WHO Website
In the Republic of the Philippines, the national policy on TM/CAM was issued in 1997. No laws or regulations have yet been issued. There is no information available on the existence of a national programme on TM/CAM. The national office, the Philippine Institute of Traditional and Alternative Care, was founded in 1997. It is administered by the Department of Health. There is no national expert committee on TM/CAM. The National Integrated Research Programme on Medicinal Plants of the Philippine Council of Health Research and Development serves as the national research institute on herbal medicines.
The regulations on herbal medicines were issued in 1984; these regulations are separate from those for conventional pharmaceuticals. Herbal medicines are regulated as over the counter medicines. By law, medical claims may be made for herbal medicines with supporting scientific proof.
Pending the development of the national pharmacopoeia, the United States pharmacopoeia, the Japanese pharmacopoeia and the ESCOP monographs are used and are considered to be legally binding. Pending the development of national herbal monographs, herbal monographs from a number of foreign pharmacopoeias are used; however, they are not legally binding.
Manufacturing requirements for herbal medicines are the same as the GMP rules for conventional pharmaceuticals. A control mechanism exists to ensure implementation of these requirements;
WHO Traditional Medicine Strategy.pdf 1285 Kb
Source: WHO Website
A traditional medicine strategy is relevant:
Traditional medicine continues to play an important role in health care. In many
parts of the world, it is the preferred form of health care. Elsewhere, use of herbal medicines and so-called complementary and alternative therapies is increasing dramatically. There is no single determinant of popularity. But cultural acceptability of traditional practices, along with perceptions of affordability, safety and efficacy and questioning of the approaches of allopathic medicine, all play a role. In view of this broad appeal, the general lack of research on the safety and efficacy of traditional medicines is therefore of great concern.
A traditional medicine strategy is urgently needed: International, national and nongovernmental agencies continue to make great efforts to ensure that safe, effective and affordable treatments for a wide range of diseases are available where they are most needed. WHO estimates, however, that one-third of the worlds population still lacks regular access to essential drugs, with the figure rising to over 50% in the poorest parts of Africa and Asia. Fortunately, in many developing countries, traditional medicine offers a major and accessible source of health care. Use of traditional medicine in primary health care, however, especially in the treatment of deadly diseases, is cause for concern. An evidence-base supporting its safe and efficacious use has yet to be developed.
A traditional medicine strategy has been developed: In response to these challenges, WHO has developed a strategy for traditional medicine to enable this form of health care to better contribute to health security.
It focuses on working with WHO Member States to define the role of traditional medicine in national health care strategies, supporting the development of clinical research into the safety and efficacy of traditional medicines, and advocating the rational use of traditional medicine.
WHO Traditional Medicine Strategy.pdf 499 Kb
Source: WHO Website
The safety of medicines is an essential part of patient safety. Global drug safety depends on strong national systems that monitor the development and quality of medicines, report their harmful effects, and provide accurate information for their safe use.
Harmful, unintended reactions to medicines that occur at doses normally used for treatment are called adverse drug reactions (ADRs). ADRs are among the leading causes of death in many countries.
Preventing and detecting adverse effects from medicines is termed pharmacovigilance. Vigilant assessment of the risks and benefits of medicines applies throughout the life cycle of a medicine - from the pre-approval stage to use by patients.
Global information-sharing on adverse effects strengthens drug safety in countries, and can translate into timely policy decisions that safeguard patient safety when problems emerge.
Safe Medicine.doc 56 Kb
