Last updated: December 21, 2007

The World Health Organization (WHO) was established in 1948 as a specialized agency of the United Nations. WHO is made up of 193 Member States, most of which are also UN Member States. WHO’s mission is “the attainment by all peoples of the highest possible level of health.”

WHO has a mandate to “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products” (Article 2, WHO Constitution). WHO provides expertise and guidance on these issues through the development and implementation of international standards and guidelines for the safety, quality, and efficacy of medicines.

Globalization and the international production of pharmaceuticals are making the WHO’s drug regulation harmonization efforts ever more important and valuable to its Member States. For example, one of WHO’s tasks is to “help countries consider the implications of the relevant harmonization agreements” such as those of the ICH (an organization that does not include all of the developing countries). WHO evaluates the impact of the ICH guidelines on these countries, and then advises them on how to adopt the guidelines.

Relevant Programs

International Programme on Chemical Safety

The primary goals of the International Programme on Chemical Safety (IPCS) “are to establish the scientific basis for safe use of chemicals, and to strengthen national capabilities and capacities for chemical safety.” The IPCS is a joint program between the WHO, the International Labour Organization (ILO), and the United Nations Environment Programme (UNEP), and is administered by the WHO. Other organizations that the IPCS works with are the Food and Agriculture Organization (FAO) of the United Nations (UN), other UN agencies, and the Inter-Organization Programme for the Sound Management of Chemicals (IOMC). Collectively, these organizations work with governments, non-governmental organizations, and scientific institutions to promote the sound management of chemicals.

The key work areas of the IPCS are:

• Chemicals assessment
• Methods for chemicals assessment
• Chemicals in food
• Poisons information, prevention, and management
• Chemicals incidents and emergencies
• Capacity building

The IPCS supports initiatives such as the World Summit on Sustainable Development (WSSD) Global Partnership for Capacity Building to Implement the Globally Harmonized System for Classification and Labeling of Chemicals (GHS), which promotes capacity building, especially in developing countries, for chemical labeling and safety measures for industrial and agricultural chemicals, and chemicals in transport. IPCS is involved in activities to assist countries in implementation of the GHS by 2008.

The primary activities of the IPCS of interest to AltTox.org users would be their work in chemicals assessment and methods for chemicals assessment.

Chemicals Assessment

IPCS plays an international role in the preparation of risk assessments on specific chemicals–documents especially useful to developing countries. IPCS products are being made consistent with the GHS to enable their use in national implementation of the GHS.

IPCS products include:

• Concise International Chemical Risk Assessment Documents
• Environmental Health Criteria
• Health and Safety Guides
• International Chemical Safety Cards
• Pesticide Data Sheets
• WHO Recommended Classification of Pesticides by Hazard

IPCS has a goal “to engage health professionals in its chemical assessment activities.” Practical applications here include development and harmonization of precautionary statements and safety sheets for the GHS. Health professionals are also seen as a resource for existing information on human exposures to chemicals that could be useful in GHS-based hazard assessments.

The IPCS has been involved in several projects on endocrine disruptors:

• Publication of the Global assessment of the state-of-the-science of endocrine disruptors
• Report of the IPCS-Japan workshop on Endocrine disruptors – research needs and future directions

Methods for Chemicals Assessment

IPCS plays an international role in developing and harmonizing hazard and risk assessment methods. The work of the IPCS in developing methods for chemicals assessment “aims at promoting the development, harmonization and use of generally acceptable, scientifically sound methodologies for the evaluation of risks to human health and the environment from exposure to chemicals.” To avoid duplication of efforts, the IPCS and the Organization for Economic Cooperation and Development (OECD) work cooperatively in the field of risk assessment methodologies.

Some of the projects on methods for chemicals assessment carried out by the IPCS are:

• Publications on risk assessment methodologies – Environmental Health Criteria
• IPCS Harmonization Project
• Risk assessment challenges on emerging scientific issues such as toxicogenomics
• Human Data Initiative
• Integrated Risk Assessment

Some examples of the WHO/IPCS Harmonization Project activities include:

PBPK (physiologically-based pharmacokinetic) modeling

• Promote best practice in PBPK modeling
• Produce high-level guidance document on “Principles of Characterizing and Applying PBPK Models” that will be released for comment in 2008
• Convene international workshop late 2008/early 2009

Mutagenicity

• Mutagenicity Testing document (comments closed Nov. 2007)

Immunotoxicity risk assessment

• WHO/IPCS Environmental Health Criteria documents on immunotoxicology
• WHO Collaborating Centre for Immunotoxicity and Hypersensitivity at RIVM, Bilthoven, Netherlands
• Experts meeting to develop guidance on immunotoxicity risk assessment Feb. 28-29, 2008

Skin Sensitization

• Report of 2006 Berlin Sensitization Workshop accepted for publication in Regulatory Toxicology and Pharmacology

Non-Cancer Mode of Action

• Critical Reviews in Toxicology article on the IPCS non-cancer human relevance framework and three case studies expected early 2008

Inter-Organization Programme for the Sound Management of Chemicals

The purpose of the Inter-Organization Programme for the Sound Management of Chemicals (IOMC) is “to strengthen cooperation and increase coordination in the field of chemical safety.”

WHO administers the IOMC, which is composed of the following seven Participating Organizations, and two observer organizations (the United Nations Development Programme (UNDP) and the World Bank):

• Food and Agriculture Organization of the United Nations (FAO)
• International Labour Organization (ILO)
• Organisation for Economic Co-operation and Development (OECD)
• United Nations Environment Programme (UNEP)
• United Nations Industrial Development Organization (UNIDO)
• United Nations Institute for Training and Research (UNITAR)
• World Health Organization (WHO)

The key work areas of the IOMC, all related to chemical safety, are identified as:

• risk reduction
• knowledge and information
• governance
• capacity-building
• technical cooperation
• illegal traffic

The IOMC endorsed the Strategic Approach to International Chemical Management (SAICM) in 2006. IOMC organizations are assisting countries in adopting these projects for chemicals management.

A few examples of IOMC activities, where they have provided technical assistance, guidance, training, and capacity building for countries, are:

• Establishing and implementing a Globally Harmonized System for the Classification and Labeling of Chemicals (GHS), in the area of health and environmental hazards
• Addressing the problems of obsolete/unwanted pesticides in Africa
• Assessing Existing Chemicals, through sharing the burden of information gathering, testing, assessment of High Production Volume Chemicals among OECD countries and identifying the needs for further work on such chemicals
• Supporting countries to implement the Stockholm Convention on POPs (Persistent Organic Pollutants) and to develop their National Implementation Plans (NIPs)

Specific programs of the IOMC are discussed in the following sections.

Codex Alimentarius Commission

The Codex Alimentarius Commission (CAC) of WHO’s Food and Agriculture Organisation (FAO) develops standards, guidelines, and other recommendations to protect consumers regarding the quality and safety of food. Their activities also aim to ensure fair food trade practices and harmonization of international food standards.

International Pharmacopoeia

The WHO Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations conducts the activities of the International Pharmacopoeia in collaboration with industry and other organizations.

The International Pharmacopoeia, the 4^th edition, provides a collection of monographs for pharmaceutical substances’ active ingredients and excipients, dosage forms, radiopharmaceuticals, methods of analysis, and test reagents. Simple quality and analytical methods are adopted when possible, so the methods can be carried out by all countries. The International Pharmacopoeia can be used by WHO Member States, either as reference material or it can be incorporated into national legislation by Member States as their pharmacopoeial requirements. The International Pharmacopoeia has no legal status unless incorporated into a nation’s legislation.

WHO also provides a list of national and regional pharmacopoeias, the Index of Pharmacopoeias.

As part of their work on the quality assurance of medicines, WHO provides guidance on good manufacturing practice (GMP). These guidelines cover safety, quality, and efficacy in the production of pharmaceuticals for Member States not having their own quality assurance guidelines.

International Agency for Research on Cancer

The International Agency for Research on Cancer (IARC) is part of the World Health Organization. “IARC’s mission is to coordinate and conduct research on the causes of human cancer [and] the mechanisms of carcinogenesis, and to develop scientific strategies for cancer control.” Their research is focused on the relationship of human cancer to man’s environment. The IARC is not involved in policy or legislation regarding carcinogens.

Quality, Safety and Efficacy of Medicines (QSM)

The Quality, Safety and Efficacy of Medicines (QSM) is part of WHO’s Medicines Programme. The QSM is involved in the following activities: quality assurance of medicines, regulation and legislation, and safety and efficacy of medicines. Their activities are aimed at strengthening national drug regulatory agencies (DRAs) in developing countries by providing relevant expertise and technical assistance.

Interagency Pharmaceutical Coordination Group

Pharmaceutical advisors to leading world organizations such as the WHO, the World Bank, and the United Nations make up the Interagency Pharmaceutical Coordination (IPC) group. The purpose of the IPC is to coordinate the pharmaceutical industry policy advice provided to countries as well as provide coordinated advice on the development of interagency technical documents.

International Conference of Drug Regulatory Authorities

The conferences of the International Conference of Drug Regulatory Authorities (ICDRA) are forums for the drug regulatory authorities of Member States to work together to prioritize regulatory issues, exchange information, and discuss collaborative approaches. The ICDRA has played an important role in international harmonization efforts for drug regulations, and quality, safety, and efficacy standards.