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

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WHO MEDICINES STRATEGY 2004-2007 | 106EO 6.6Prequalification (initial assessment,ongoing monitoring andprequalification) of products andmanufacturers of medicines forpriority diseases and of qualitycontrol laboratories, as appropriate,through procedures and guidelinesappropriate for this activityThis expected outcome comprises three activities:> finalization of the Model Quality AssuranceSystem.> prequalification of products andmanufacturers for products used in thetreatment of HIV/AIDS, TB, and malaria.> prequalification of quality control laboratories.1 Finalization of the Model QualityAssurance SystemRationaleThe objective is to finalize a model, based onnorms and standards for procurement agencies,that will ensure that all UN partners follow thesame process and procedure in procurementactivities, meeting international standards. Thisincludes good practices for prequalification,purchasing, storage, and distribution.ProgressThe third draft of the Model Quality AssuranceSystem is in the final stages and was discussed ata meeting of the IPC in New York in November2003, involving UN procurement organizationsand NGOs.Challengesor resources needed to implement qualitysystems for prequalification of productsand manufacturers, purchasing, storage,and distribution that meet internationalrecommendations. The challenge will beto harmonize the process and procedurein procurement activities amongst theseorganizations as well as to target the level atwhich the minimum standards should be set forthe Model Quality Assurance System.2 Prequalification of products andmanufacturers for products used inthe treatment of HIV/AIDS, TB, andmalariaRationaleThe prequalification of products andmanufacturers aims to assess product data andinformation as well as manufacturing sites, toestablish whether these meet internationallyrecommended norms and standards establishedby WHO. The objective is to ensure that onlyproducts meeting acceptable quality standardswill be procured. Purchasing or sourcing ofproducts that have not been prequalified frommanufacturers that are not prequalified mayresult in the supply of substandard or counterfeitproducts, or of products that do not meetspecifications, norms, and standards in relation tosafety, efficacy or quality — with obvious risks forthe patient.ProgressFollowing the launch by WHO of theprequalification project, over 400 product dossiershave been assessed and several manufacturingsites have been inspected. To date, more than 50products (including both innovator and genericproducts) have been found to meet the WHOnorms and standards. These are included in a listof prequalified products and manufacturers.Many organizations do not have the infrastructure
COMPONENTS OF THE STRATEGY | 107Challenges remainingSeveral substances and products are not includedin pharmacopoeia monographs. Some substanceshave specific properties which make assessmentmore difficult (e.g. chirality). Not all productscan be considered either innovator or genericproducts. The number of manufacturers of ActivePharmaceutical Ingredients (APIs) and finishedproducts such as those used in the treatment ofmultidrug-resistant TB are limited. The number ofmanufacturers of APIs and finished products suchas artemisinin and its derivatives, as well as theartemisinin combination therapy (ACT) products,are limited. In addition, some manufacturers donot have the resources to improve compliancewith GMP. Not all manufacturers have generatedall the required data to prove safety, efficacy, andquality of their products. More time is needed tomeet the target of prequalifying a certain numberof products and manufacturers.3 Prequalification of quality controllaboratoriesRationaleInterested quality control laboratories will beassessed as part of a prequalification procedure.The assessment should indicate whether theselaboratories meet international standards asdefined by WHO in GMP and Good Practice forPharmaceutical Control Laboratories. The resultsof analysis of products obtained from laboratoriesnot meeting international standards may beinaccurate.ProgressWHO has established norms and standards forquality control laboratories. A procedure for theprequalification of laboratories has already beendeveloped.Challenges remainingThere is a need to encourage laboratories toparticipate in the prequalification processand establish whether these laboratories havethe capability to perform analysis of complexproducts.Meeting the challenges 2004-2007Over the next four years WHO will:> establish the Model Quality AssuranceSystem through negotiation and discussion,targeting it at a level that meets minimumrequirements for norms and standards, toallow procurement organizations to establishand implement a quality control system.> improve awareness of the requirements,norms, and standards through the assessmentand appropriate training of regulators andindustry, resulting in improved regulatorycontrol of products.> assess quality control laboratories forcompliance with international standards aspart of the prequalification project.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of products assessed and approved na na na 93 na na
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