WHO PReQuaLiFicatiOn PROgRamme

PROgramme backgroundMILLENNIUM DEVELOPMENT GOALSEach of the impacts described above is contributing toachieving the following targets set under the MillenniumDevelopment Goals:• Target 7: to have halted by 2015 and begun to reverse thespread of HIV/AIDS• Target 8: to have halted by 2015 and begun to reverse theincidence of malaria and other major diseases• Target 17: in cooperation with pharmaceutical companies,provide access to affordable, essential drugs in developingcountries.WHO’s prequalification activities are clearly a critical step inthe pathway to expanding access to priority medicines. AsThe Lancet comments: “...prequalification status means thatsome of the most important drugs are being made safelyavailable in parts of the world where they are most needed.” a• Guideline on submission of documentation forprequalification of multi-source (generic) finishedpharmaceutical products (FPPs) used in thetreatment of HIV/AIDS, malaria and tuberculosis• Note to applicants expressing interest forsupplying artemisinin-containing drug products:bioequivalence, or efficacy and safety issues.New guidance documents were also posted on theweb-site:• Guidelines for registration of fixed-dose combinationmedicinal products. This guidance document wasadopted by the 39 th WHO Expert Committee onSpecifications for Pharmaceutical Preparationsand published (2005) as Annex 5, WHOTechnical Report Series No. 929.• Additional guidance for organizations performingin vivo bioequivalence studies. This guidancedocument was adopted by the 40 th WHO ExpertCommittee on Specifications for PharmaceuticalPreparations and published (2006) as Annex 9,WHO Technical Report Series No. 937.• Guidance on variations to a prequalified dossier• Note to applicants on the choice of comparatorproducts for the Prequalification Programme.programme activities in 2005Several guidance documents were translated intoFrench:photo © L’IV Com/Irene Lengui• Good practices for national pharmaceutical controllaboratories• Guidelines for preparing a laboratory information file• Procedure for assessing the acceptability, inprinciple, of quality control laboratories for use byUnited Nations agencies.Several Invitations for Expression of Interest wereposted on the Prequalification Programme’s web-site:a The Lancet, 20 November 2004, 364:9448.1 Established by Stop TB, the Global Drug Facility providesprocurement and financing services to qualified applicants,enabling governments and nongovernmental organizations toimprove the coverage and quality of global TB control throughthe acquisition of quality TB drugs.2 International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for HumanUse (ICH).3 SPCs are an important part of the information that must besubmitted to regulators before a pharmaceutical product canbe approved. They also serve as a basis for the informationprovided about the product to health care provides andpatients. (For example, in the form of a package leaflet thatmust accompany each pharmaceutical product.)4 A comparator product is used to test the quality of bothinnovator products and their generic alternatives, and toensure that two substances under investigation are chemicallyidentical.5 OTECI is a French nongovernmental organization. It enablesretired professionals with experience in, for example, thehealth, agricultural or textile sectors, to contribute theirexpertise to development programmes.6 Good clinical practice.• 6 th Invitation for Expression of Interest (EOI):HIV and related diseases — October 2005.• 6 th Invitation for Expression of interest (EOI):Antituberculosis — May 2005.• 4 th Invitation for Expression of Interest (EOI):Artemisinin-based antimalarial products —May 2005.INFORMATION MANAGEMENTA database was developed in 2005 to log andtrack dossier assessment, inspections, etc.It also incorporates all correspondence withmanufacturers, as well as assessment andinspection reports.WHO PREQUALIFICATION PROGRAMME10