who medicines strategy - libdoc.who.int - World Health Organization
who medicines strategy - libdoc.who.int - World Health Organization who medicines strategy - libdoc.who.int - World Health Organization
WHO MEDICINES STRATEGY 2004-2007 | 86EO 5.1Pharmaceutical norms, standardsand guidelines developed orupdated to promote good practicein quality assurance and regulatorymattersRationaleExisting WHO pharmaceutical norms, standards,and guidelines have to be continually updatedto keep pace with advances in pharmaceuticalscience and technology. Today, as efforts getunder way to scale up access to quality essentialmedicines in developing countries, there is anurgent need for WHO to further strengthen thedevelopment of international standards andguidelines on the assessment of multi-sourcegeneric products.In addition, the continuing sale of substandardand counterfeit medicines in some countrieshas highlighted the need for internationalagreements in order to strengthen existingpreventive measures. Elsewhere, increasing tradeand commerce, and the supply of life-savingmedicines by both private and public parties,require new approaches to quality assurance atthe international, regional, and national level.The statutory instruments, advice, andrecommendations provided by the WHO ExpertCommittee on Specifications for PharmaceuticalPreparations can help national authorities,especially national drug regulatory authoritiesand procurement agencies, to combat problemssuch as the production, distribution, and sale ofsubstandard and counterfeit medicines, financialwaste, and the emergence of resistance tomedicines for priority infectious diseases.ProgressWHO has helped raise awareness of the needfor regulatory measures covering the safety ofand trade in starting materials, including activepharmaceutical ingredients and excipients,and the implementation of GMP. In responseto a Resolution of the World Health Assembly(WHA52.19) and recommendations made invarious fora, including the 10 th InternationalConference of Drug Regulatory Authorities, theExpert Committee has adopted new mechanismsfor the control and safe trade of starting materialsfor pharmaceuticals, for action by governments,manufacturers, traders and brokers: (1) GoodTrade and Distribution Practices (GTDP); and (2)Pharmaceutical Starting Materials CertificationScheme (SMACS). Member States are beingencouraged to participate in a pilot phase.The Expert Committee has updated widely usedexisting WHO guidelines on GMP and addedspecific texts such as Guidelines on GoodManufacturing Practices for RadiopharmaceuticalProducts and the Model Certificate of GoodManufacturing Practices.A series of guidance texts have been adoptedby the Expert Committee in relation to theprequalification of suppliers of medicines for HIV/AIDS, TB, and malaria, including:> Procedure for assessing the acceptability, inprinciple, of pharmaceutical products forpurchase by UN agencies> Procedure for assessing the acceptability, inprinciple, of quality control laboratories foruse by UN agencies.
COMPONENTS OF THE STRATEGY | 87> Guidelines for drafting a laboratoryinformation file.> Procedure for assessing the acceptability, inprinciple, of procurement agencies for use byUN agencies.> Guidelines for drafting a procurement agencyinformation file.> Interim guidelines for the assessment of aprocurement agency.> Model Quality Assurance System for theprequalification, procurement, storage, anddistribution of pharmaceutical products.ChallengesCountries’ priorities, needs, resources, andrequirements in pharmaceuticals differsubstantially. This has enormous implicationsfor WHO’s work, both in developing globalguidelines and advising Member States on theiradaptation and adoption. Current developmentsin the international harmonization of drugregulation provide an opportunity for WHOto review and update existing standards andguidelines.Today, WHO is at the forefront of continuinginternational efforts to define and harmonizeclear and practical standards and guidelinesfor pharmaceuticals, particularly in responseto the increasing globalization of trade inpharmaceuticals and the supply of medicines byintermediaries. Additional regulatory guidanceis also urgently needed for the assessment ofthe quality, safety, and efficacy of fixed-dosecombination medicines for public health prioritydiseases.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to review, update, and developnorms, standards, and guidelines forquality assurance and quality assessment inmedicines registration .> improve the dissemination and promotionof WHO guidelines (e.g. quality assuranceguidance, GMP guidelines) and strengthencommunication strategies in order to ensureeffective implementation of the guidelines.> establish a Global Alliance for the Quality ofPharmaceuticals, in collaboration with otherpartners, with a particular focus on capacitybuilding in quality assurance at the nationallevel.OUTCOME INDICATORS1999 2003 2007No. of countries using the WHO Certification Scheme aspart of the marketing authorization process#REPORTING % TARGET#REPORTING % TARGETna na na 87/135 64% 75%
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COMPONENTS OF THE STRATEGY | 87> Guidelines for drafting a laboratoryinformation file.> Procedure for assessing the acceptability, inprinciple, of procurement agencies for use byUN agencies.> Guidelines for drafting a procurement agencyinformation file.> Interim guidelines for the assessment of aprocurement agency.> Model Quality Assurance System for theprequalification, procurement, storage, anddistribution of pharmaceutical products.ChallengesCountries’ priorities, needs, resources, andrequirements in pharmaceuticals differsubstantially. This has enormous implicationsfor WHO’s work, both in developing globalguidelines and advising Member States on theiradaptation and adoption. Current developmentsin the <strong>int</strong>ernational harmonization of drugregulation provide an opportunity for WHOto review and update existing standards andguidelines.Today, WHO is at the forefront of continuing<strong>int</strong>ernational efforts to define and harmonizeclear and practical standards and guidelinesfor pharmaceuticals, particularly in responseto the increasing globalization of trade inpharmaceuticals and the supply of <strong>medicines</strong> by<strong>int</strong>ermediaries. Additional regulatory guidanceis also urgently needed for the assessment ofthe quality, safety, and efficacy of fixed-dosecombination <strong>medicines</strong> for public health prioritydiseases.Meeting the challenges 2004-2007Over the next four years WHO will:> continue to review, update, and developnorms, standards, and guidelines forquality assurance and quality assessment in<strong>medicines</strong> registration .> improve the dissemination and promotionof WHO guidelines (e.g. quality assuranceguidance, GMP guidelines) and strengthencommunication strategies in order to ensureeffective implementation of the guidelines.> establish a Global Alliance for the Quality ofPharmaceuticals, in collaboration with otherpartners, with a particular focus on capacitybuilding in quality assurance at the nationallevel.OUTCOME INDICATORS1999 2003 2007No. of countries using the WHO Certification Scheme aspart of the marketing authorization process#REPORTING % TARGET#REPORTING % TARGETna na na 87/135 64% 75%