WHO Traditional Medicine Strategy: 2002-2005: Chapter Five: Strategy and plan of action 2002 - 2005: 5.2 Safety, efficacy and quality: Promote the safety, efficacy and quality of TM/CAM by expanding the knowledge-base on TM/CAM, and by providing guidance on regulatory and quality assurance standards

WHO Traditional Medicine Strategy: 2002-2005
(2002; 70 pages) [French] [Spanish]

Table of Contents

	Acknowledgements
	Acronyms, abbreviations and WHO Regions
	Key points: WHO Traditional Medicine Strategy 2002 - 2005
		What is traditional medicine?
		Widespread and growing use
		Why such broad use?
		Uncritical enthusiasm versus uninformed scepticism
		Challenges in developing TM/CAM potential
		The current role of WHO
		Framework for action
		Strategy implementation
	Chapter One: Global review
		1.1 What is traditional medicine? Towards a working definition
		1.2 Broad use and appeal
		1.3 Expenditure
		1.4 Accounting for use and increasing interest
		1.5 Responding to the popularity of TM/CAM
	Chapter Two: Challenges
		2.1 What needs to be done?
		2.2 National policies and legal framework
		2.3 Safety, efficacy, quality
		2.4 Access
		2.5 Rational use
	Chapter Three: The current role of WHO
		3.1 Developing TM/CAM and integrating it into national health care systems
		3.2 Ensuring appropriate, safe and effective use of traditional medicine
		3.3 Increasing access to TM/CAM information
	Chapter Four: International and national resources for traditional medicine
		4.1 UN Agencies
		4.2 International organizations
		4.3 Nongovernmental organizations
		4.4 Global professional associations
		4.5 International and national professional associations
		4.6 Specific initiatives
	Chapter Five: Strategy and plan of action 2002 - 2005
		5.1 Policy: Integrate TM/CAM with national health care systems, as appropriate, by developing and implementing national TM/CAM policies and programmes
		5.2 Safety, efficacy and quality: Promote the safety, efficacy and quality of TM/CAM by expanding the knowledge-base on TM/CAM, and by providing guidance on regulatory and quality assurance standards
		5.3 Access: Increase the availability and affordability of TM/CAM, as appropriate, with an emphasis on access for poor populations
		5.4 Rational use: Promote therapeutically sound use of appropriate TM/CAM by providers and consumers
	Annex One: List of WHO Collaborating Centres for Traditional Medicine
	Annex Two: Selected WHO publications and documents on traditional medicine
		National policy and monitoring
		Quality, safety and efficacy
		Rational use
		WHO Collaborating Centres for Traditional Medicine
	References
	Back Cover

5.2 Safety, efficacy and quality: Promote the safety, efficacy and quality of TM/CAM by expanding the knowledge-base on TM/CAM, and by providing guidance on regulatory and quality assurance standards

Components

• Evidence-base for TM/CAM. Increase access to and extent of knowledge of the safety, efficacy and quality of TM/CAM, with an emphasis on priority health problems such as malaria and HIV/AIDS.

• Regulation of herbal medicines. Support countries to establish effective regulatory systems for registration and quality assurance of herbal medicines.

• Guidelines on safety, efficacy and quality. Develop and support implementation of technical guidelines for ensuring the safety, efficacy and quality control of herbal medicines and other TM/CAM products and therapies.

WHO strategy

WHO will strengthen and expand its existing global expert TM/CAM network, members of which include WHO Collaborating Centres, national health authorities, academic and scientific institutions, and other relevant international agencies such as EMEA, the European Pharmacopoeia, FAO, the Organization of African Unity and UNIDO. Working with these partners it will continue to develop technical guidelines and scientific information, particularly on herbal medicines. The Organization will also expand its TM/CAM evidence-base, with a view to identifying which TM/CAM therapies are of proven safety and efficacy, and to generate greater public health credibility for TM/CAM. It will do this through technical review of clinical use of TM/CAM in the prevention, treatment and management of common diseases and conditions, and further support to clinical research into the safety and efficacy of TM/CAM.

WHO Headquarters and Regional Offices will establish a global regulatory network of safety monitoring systems on herbal medicines and other TM/CAM therapies. This will include helping countries establish post-marketing surveillance for herbal medicines. WHO will continue to cooperate with relevant professional associations and academic institutions to develop and provide guidelines for basic training in certain manual therapies. It will also organize training programmes and workshops for national authorities to upgrade their knowledge of safety and efficacy issues regarding herbal medicines.

Critical indicator

Strategy objective	Number of WHO Member States reporting laws and regulations on herbal medicines/Total number of WHO Member States	1999 status	2005 target
WHO Member States with laws and regulations on herbal medicines	65/191	34%	40%

Expected outcomes for 2002 - 2005

• Increased access to and extent of knowledge of TM/CAM through net-working and exchange of accurate information.

• Technical reviews of research on use of TM/CAM for prevention, treatment and management of common diseases and conditions.

• Selective support for clinical research into use of TM/CAM for priority health problems such as malaria and HIV/AIDS, and common diseases.

• National regulation of herbal medicines, including registration, established and implemented.

• Safety monitoring of herbal medicines and other TM/CAM products and therapies.

• Technical guidelines and methodology for evaluating safety, efficacy and quality of TM/CAM.

• Criteria for evidence-based data on safety, efficacy and quality of TM/CAM therapies.