WHO TRS (Technical Report Series) 1003, 2017 Annex 1


WHO TRS (Technical Report Series) 1003, 2017 Annex 1

WHO guidelines for selecting marker substances of herbal origin for quality control of herbal medicines

1.1 Background:

With the constant increase in the use of herbal medicines worldwide and the rapid expansion of the global market for them, the safety and quality of herbal materials and finished herbal products has become a major concern for health authorities, pharmaceutical industries and the public. The safety and efficacy of herbal medicines largely depend on their quality. Requirements and methods for quality control of finished herbal products, particularly for mixture herbal products, are far more complex than for chemical medicines. The quality of finished herbal products is also influenced by the quality of the raw materials used.

The World Health Assembly resolution on traditional medicine (WHA56.31), adopted in May 2003, requested WHO to provide technical support to develop methodology to monitor or ensure the quality, efficacy and safety of herbal products.

The International Conference of Drug Regulatory Authorities (ICDRA) in 2002 and 2004, as well as the Meetings of National Centres Participating in the WHO Programme of International Drug Monitoring (in 2000, 2001, 2002 and 2003) requested WHO to develop and continuously update the technical guidelines on quality, safety and efficacy of herbal medicines. One of the challenges in analysing the cause of adverse events reported in connection with use of herbal medicines is the lack of expertise in identifying and testing ingredients and constituents of suspect herbal products at the national pharmacovigilance centres, and/or national quality control laboratories.

To reduce the proportion of adverse events attributable to poor quality of  herbal medicines, WHO has committed to developing new guidelines on quality assurance and control of herbal medicines, as well as to updating existing ones.

As a follow-up to the WHO Informal Meeting on Methodologies for Quality Control of Finished Herbal Products, held in Ottawa, Canada in July 2001, WHO decided to develop four new documents to provide technical guidance at the key stages where quality control is required in production of herbal medicines:

(1) WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants (published in 2003) (1);

(2) WHO guidelines on assessing quality of herbal medicines with reference to contaminants and residues (published in 2007) (2);

(3) Good processing practices for herbal materials (in preparation); and

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Table of Contents

1. Introduction 

1.1 Background 

1.1.1 Preparation of the document 

1.2 Objectives 

1.3 Glossary 

1.3.1 Terms related to herbal medicines 

1.3.2 Terms related to constituents of herbal medicines 

1.3.3 Terms related to standardization and quality control of herbal materials and herbal preparations 

2. Selection criteria for substances of herbal origin relevant for standardization and quality control of herbal medicines 

2.1 General considerations in the standardization and quality control of herbal materials, herbal preparations and herbal medicines 

2.2 Purpose and expected functions of relevant marker substances 

2.2.1 Marker substances of constituents with known therapeutic activity 

2.2.2 Marker substances of constituents with recognized pharmacological activities 

2.2.3 Marker substances of characteristic constituents 

2.2.4 Marker substances for toxic constituents 

2.3 Use of reference materials 

3. Analytical methods for substances of herbal origin in herbal medicines 

3.1 General considerations regarding the test methods to be employed 

3.2 Monographs 

References and bibliography

WHO TRS (Technical Report Series) 1003, 2017 Annex 1:

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