who medicines strategy - libdoc.who.int - World Health Organization

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WHO MEDICINES STRATEGY 2004-2007 | 84From the outset, WHO has worked to establishand promote international standards for thequality of pharmaceuticals. Under Article 2 of theWHO Constitution, WHO is required to “develop,establish and promote international standardswith respect to food, biological, pharmaceuticaland similar products”.Without assurance that medicines are relevantto priority health needs and that they meetacceptable standards of quality, safety, andefficacy, any health service is evidentlycompromised. In developed countries,considerable administrative and technical effort isdirected to ensuring that patients receive effectivemedicines of good quality. It is crucial to theobjective of health for all that a reliable system ofmedicines control is brought within the reach ofevery country.The existence of international harmonizationinitiatives in different parts of the worlddemonstrates the importance that governmentsattach to drug regulation; at the same time, itoffers opportunities for countries to review andimprove their regulatory systems. 42Member States continue to look to WHO forguidelines on the development of pharmaceuticalregulation, legislation, and quality assurance.In response, the WHO Expert Committee onSpecifications for Pharmaceutical Preparationshas adopted a large number of guidelines inthe area of quality assurance 43 . Guidelines havebeen adapted by Member States or regionalharmonization groups to meet their own needsand circumstances.Another critical pharmaceutical serviceprovided by WHO is the system of InternationalNonproprietary Names (INN), which is used toidentify each pharmaceutical substance or activeingredient by a unique and universally accessiblename. This function is fundamental to ensurethat dispensing and prescribing is governed by acommon nomenclature allowing communicationamong health professionals and consumers.This is of increasing importance in view of theglobalization of trade in pharmaceuticals and theneed for better communication among healthprofessionals. The existence of several names forthe same product can be a source of confusionand a potential risk to health.The WHO Expert Committee on Specificationsfor Pharmaceutical Preparations meets regularlyand publishes statements, guidelines, andrecommendations that provide the tools for
COMPONENTS OF THE STRATEGY | 85quality assurance systems worldwide 44 . Importantkey elements are quality assurance guidancetexts in the areas of production, testing, anddistribution of medicines. These include guidanceon: good manufacturing practices; qualityassurance for regulatory approval; prequalificationof medicines, laboratories, and supply agencies;model certificates for quality assurancerelatedactivities; quality control testing; newspecifications for inclusion in the Basic Testsseries and the International Pharmacopoeia; andInternational Chemical Reference Standards.All these elements are intended for use bynational regulatory authorities, manufacturers,and other interested parties. The InternationalPharmacopoeia is in widespread use throughoutthe world and plays a major role in defining thespecifications of pharmaceutical products. It alsoprovides a valuable tool in the quality control ofimported products 45 .control, nomenclature, and classification ofpharmaceuticals.WHO will work to strengthen andpromote global norms, standards,and guidelines for the quality,safety, and efficacy of medicine.The need to scale up access to affordable qualitymedicines for HIV/AIDS, TB, and malaria indeveloping countries has raised many challengeswithin the pharmaceutical world. Thesechallenges come on top of the reality that amongnational regulatory authorities there is a variablecapacity to interpret and apply existing norms andstandards and guidelines on regulation, quality
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REFERENCES | 1471Annual report 2000
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REFERENCES | 14912 th Model List of
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