World Health Organization harmonization

In 1975 the World Health Organization produced a guideline for the establishment, maintenance and distribution of chemical reference substances (WHO 1975). This document was intended to foster collaboration and harmonization of approval for the provision of reference substances by national authorities and organizations responsible for reference substances collections. This guideline was revised in 1982 (WHO 1982) and a further revision was completed more recently (WHO 1999) to take into account progress in pharmaceutical analysis. The latest guidehne defines both primary chemical reference substance and secondary chemical reference substance as follows ... 

However, the establishment of a new endotoxin standard by the World Health Organization is a recent example of successful international collaboration between the World Health Organization, the United Stated Pharmacopoeia and the European Pharmacopoeia (Poole et al. 1997). Thus this standard is available from any of these organizations to be employed as a reference in the harmonized Limulus Amoebocyte Lysate test. 

Periodic discussions among the EP, JP, and USP, with the World Health Organization as observer, facilitate compendial harmonization. This association is known as the Pharmacopeial Discussion Group (PDG). The PDG has prioritized the harmonization effort for individual general test chapters based originally on those identified within ICH Q6A (1). Dissolution is prominent on the PDG work agenda. 

World Health Organization Pharmaceutical Inspection Cooperation Scheme International Conference on Harmonization Association of Southeast Asian Nations (ASEAN) Mercado Comun del Sur (MERCOSUR)... 

IPCS (2001b) Guidance document for the use of data in development of chemical-specific adjustment factors (CSAFs) for interspecies differences and human variability in dose/ concentration-response assessment (draft). Prepared as part of the IPCS project on the Harmonization of Approaches to the Assessment of Risk from Exposure. Geneva, World Health Organization, International Programme on Chemical Safety. 

OECD/IPCS (2001) Project on the harmonization of chemical hazard/risk assessment terminology Critical analysis of survey results. Organisation for Economic Co-operation and Development and World Health Organization, International Programme on Chemical Safety (in press). 

To protect consumers health, many countries have restricted the use of pesticides by establishing legal directives on maximum residue levels (MRLs) to control their levels in food (28). These MRLs sometimes cause conflicts, because residue levels acceptable in one country may be unacceptable in others. This problem has revealed the need to harmonize the different MRLs, which have been dealt with mainly by two international organizations, the European Union (EU) at the European Level, and the Codex Alimentarius Commision of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) (28,29). 

IPCS (2004) IPCS risk assessment terminology. Part 2. IPCS glossary of key exposure assessment terminology. Geneva, World Health Organization, International Programme on Chemical Safety (IPCS Harmonization Project Document No. 1 http //www.who.int/ipcs/methods/harmonization/areas/ipcsterminologypartsland2.pdf). 

Harmonization Project Documents are a family of publications by the World Health Organization (WHO) under the umbrella of the International Programme on Chemical Safety (IPCS) (WHO/ILO/UNEP). Harmonization Project Documents complement the Environmental Health Criteria (EHC) methodology (yellow cover) series of documents as authoritative documents on methods for the risk assessment of chemicals. 

IPCS (International Programme on Chemical Safety). 1994. Report of IPCS Workshop on the Harmonization of Risk Assessment for Reproductive and Developmental Toxicity. Oct. 17-21,1994. International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland. 

Sonich-Mullin, C., M. Callahan and S. Olin (2000). International Harmonization of Exposure Assessment Terminology and the Application of Exposure Models (abstract), on behalf of the International Programme on Chemical Safety, World Health Organization, in Proceedings of the 10th Annual Conference of the International Society of Exposure Analysis, Monterey Peninsula, CA, USA, 24-27 October, 2000. 

World Health Organization (WHO) Global Harmonization of Requirements for Medicinal Products... 

World Health Organization (WHO) Global Harmonization of Requirements for Medicinal Products / 4099 X-Ray Powder Diffractometry / 4103 Zeta Potential / 4117... 

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