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

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WHO MEDICINES STRATEGY 2004-2007 | 96the creation of a WHO Model Quality AssuranceSystem for procurement; feedback to regulatorson information collected during assessmentsof ARVs, to increase their capacity to ensurethe quality of ARVs on their national market;and regional workshops for drug regulators onregistration of generic ARVs. 51In the light of the proposed expansion of ICH intopharmacovigilance, it is a challenge for WHO to:> strengthen links with ICH to avoidunnecessary duplication> become more active in developing guidelineson pharmacovigilance> disseminate its reports and data more widely> raise awareness of its work by encouragingall Member States to participate in the WHOProgramme for International Drug Monitoring.Currently, WHO attends meetings of the ICHSteering Committee and the Global CooperationGroup with observer status; these roles areimportant and should be maintained. However,appropriate strategies for consultation andcommunication with Member States need to bedeveloped to ensure that WHO is not seen as defacto automatically endorsing ICH products, butas providing advice on the potential impact ofthose products on non-ICH Member States.WHO will contribute to thequality, safety and efficacyof all medicines assured bystrengthening and putting intopractice regulatory and qualityassurance standards
COMPONENTS OF THE STRATEGY | 97EO 6.1Medicines regulation effectivelyimplemented and monitored asthe capacity of staff is increasedthrough training activities resultingin better knowledge, organization,financing, and managementRationaleProblems related to the safety and quality ofmedicines exist in many countries throughoutthe world, developing and developed countriesalike. However, the magnitude of the problem ismuch greater in developing countries, where poorquality medicines may be the only ones to reachthe poor. Some incidents have resulted in deaths,with children often the victims. They involve theuse of medicine containing toxic substances orimpurities, medicines whose claims have not beenverified, medicines with unknown and severeadverse reactions, substandard preparations, oroutright fake and counterfeit medicines. Effectivemedicine regulation is required to ensure thesafety, efficacy, and quality of medicines availablein both the public and private sectors, as well asthe accuracy and appropriateness of medicineinformation available to health professionals andthe public.ProgressWHO has provided technical and administrativesupport to countries, including the development,publication, and dissemination of varioustools ( standards, norms, guidelines, training,and software packages) and guidance toassist in the establishment or strengthening ofnational regulatory authorities as well as theimplementation of regulatory activities.In 2002, WHO published the results of a multicountrystudy which identified some of theproblems encountered by countries in promotingeffective drug regulation. The report also providedsimple conceptual frameworks for medicineregulation, for use by policy-makers as a basis fordesigning medicine regulatory systems, as well assuggested strategies for improving drug regulationperformance. In addition, the report outlinedkey features of medicine regulatory systems indifferent countries, highlighting best practices andthe lessons to be learned. 52Challenges remainingDespite the support provided by WHO andother international organizations and donorcountries to strengthen medicine regulation,in many developing countries there remains ahuge capacity gap among national regulatoryauthorities that needs to be addressed.Meeting the challenges 2004-2007Over the next four years WHO will:> in collaboration with other partners, carryout an assessment of national medicineregulatory authorities to monitor progress,identify weaknesses, and develop strategiesin consultation with national authorities toimprove medicine regulation.> facilitate training courses in the different areasof medicine regulation and provide tools andtechnical advice as needed.OUTCOME INDICATORS1999 2003 2007No. of countries implementing basic medicines regulatoryfunctions#REPORTING % TARGET#REPORTING % TARGET70/138 51% 56% 90/130 69% 74%
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REFERENCES | 1471Annual report 2000
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REFERENCES | 14912 th Model List of
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