WHO PReQuaLiFicatiOn PROgRamme

PROgramme backgroundWHO PREQUALIFICATION PROGRAMMEVITAL TO HEALTH GOALSImagine carrying your weak and feverish child to thenearest health clinic. Imagine the doctor making hisdiagnosis and prescribing an expensive antimalarial drug.Reassured that treatment is effective, you hand overalmost all of the family’s monthly budget to pay for thepills. Now imagine that the antimalarials that your childis given are actually nothing more than a poor-qualityimitation, containing so little active ingredient that theywill ultimately fail. Counterfeit or simply poor quality?The details are not important to this family — the tragicoutcome is the same.The WHO Prequalification Programme prevents thisimaginary tale from becoming a reality for thousands ofpeople every day. It does this via stringent assessmentof product dossiers, inspection of manufacturingsites and of contract research organizations (CROs),prequalification of national pharmaceutical quality controllaboratories (NPQCLs), and advocacy for medicines ofassured quality. It is demonstrating that by making qualitypharmaceutical products available, procurement anddistribution of medicines are speeded up. This in turn helpsto maximize treatment outcomes and use of resources.PRINCIPAL OBJECTIVEExpanding the lists of prequalified medicinescontinued to be the Prequalification Programme’sprincipal objective in 2005. Assessments andinspections continued apace, resulting inprequalification of additional medicines for treatingHIV/AIDS and malaria.In 2005, more generic drugs were prequalified thanbrand-name products, illustrating the success of thePrequalification Programme in capacity building inthe generic sector. This was the first time that thebalance had tipped in favour of generics.DOSSIER ASSESSMENTSThe Programme was pleased to observe that theproduct dossiers submitted for assessment wereof a higher quality than in previous years. Theimprovement indicated that efforts to providefeedback and guidance to manufacturers followingdossier assessments had been worthwhile.Experts attended nine assessment sessions — eachof 5 days — at the UNICEF Supply Division inCopenhagen, where the product dossiers arereceived and stored. Six sessions had been planned,but due to the volume of work, nine sessions wereheld. Product dossiers relating to products fortreating HIV/AIDS, malaria and TB products wereexamined in each session.programme activities in 2005INSPECTIONSA total of 52 inspections were carried out:• 20 inspections of the manufacturing sites offinished products• 10 inspections of the manufacturing sites ofactive pharmaceutical ingredients (APIs)• 14 inspections of contract research organizations(CROs)• 8 inspections of national pharmaceutical qualitycontrol laboratories (NPQCLs) in Africa.photo © L’IV Com/Irene LenguiAn overview of inspections performed, listingmanufacturing sites, CROs and NPQCLs thatcomply with WHO norms and standards regardinggood manufacturing practice (GMP), good clinicalpractice and good laboratory practice, respectively,was added to the prequalification website.WHO PREQUALIFICATION PROGRAMME

PROgramme backgroundLaunched in 2001, partnered with UNAIDS, UNICEF and theUN Population Fund, and receiving support from the WorldBank, the Programme is tackling the quality problemscommonly associated with medicines for three highburdendiseases:• HIV/AIDS: For people living with HIV/AIDS, antiretroviral(ARV) products offer hope of prolonged survival — yetthey are not available in sufficient quality or quantitywhere they are needed most.• Malaria: Data from a recent WHO survey in six Africancountries showed that 10-65% of sampled antimalarialchloroquin tablets contained too little active ingredient.The poor quality of first-line treatments is contributingPREQUALIFICATION OF PRODUCTS FORHIV/AIDSIn 2005, 22 new antiretroviral (ARV) products wereprequalified. By the end of the year, the number ofprequalified HIV-related products had risen to 107.(The lists of prequalified products can be found at:http://mednet3.who.int/prequal/) If US Food andDrug Administration (FDA) approvals (see NewCollaboration section, page 8), are also included inthis total, the figure stands at 116. The list includes72 different ARV preparations, 16 of which aredouble or triple formations.Of the 72 prequalified ARV products, 34 are frombrand-name companies and 38 from genericscompanies. At the end of 2005, an additional105 HIV/AIDS medicines were being evaluated.programme activities in 2005to drug resistance and treatment failure.• Tuberculosis (TB): Many generic anti-TB medicineshave serious quality defects, due to their poormanufacturing quality. Also, bioequivalence has oftennot been proved.During the nine dossier assessment sessions,222 assessment reports on HIV/AIDS-relatedproducts were written. This figure does not includenumerous “ad-hoc” assessments carried out inbetween the Copenhagen sessions by WHOappointedexperts. In all, 12 GMP inspectionswere carried out for HIV/AIDS medicines,including one three-year re-inspection and fiveinspections of manufacturers of ARV APIs. Atotal of nine inspections of CROs were conducted,corresponding to more than 20 bioequivalencestudies of HIV/AIDS medicines.Quality control of ARVsThe Prequalification Programme continued tocarry out “post-approval” monitoring of the qualityof prequalified products; some of the results havebeen published. (See reference to Journal of GenericMedicines article in Publications and Informationsection, on page 9.) In 2005, it participated intwo large sampling/testing programmes of ARVproducts. Focused on post-approval quality control,the studies were carried out with relevant expertauthorities:photo © WHO/Michael JensenStudy 1: UNICEF, the French Agency for theSafety of Health products (Agence françaisede Sécurité sanitaire des Produits de Santé —AFSSAPS) and WHO worked together to sampleprequalified ARV products. Fifty-six samples foranalysis were collected from the UNICEF SupplyDivision in Copenhagen or requested from themanufacturers.Results: No problems with quality were found; onepackaging discrepancy was noted.WHO PREQUALIFICATION PROGRAMME

PROgramme backgroundHOW DOES THE PROGRAMME WORK?The Prequalification Programme makes a solid, scientificassessment — based on WHO prequalification guidelines,that are in line with internationally harmonized standards— of the quality of both generic and patented medicines.The process begins with submission to WHO, by apharmaceutical manufacturer, of an Expression of Interest,together with a product dossier. The safety, quality andefficacy information contained in the product dossieris examined by two WHO-appointed assessors. Bothassessors must approve its contents. If they disagree, orif the product is particularly complex, additional assessorsare generally consulted. When the dossier is close toapproval, inspection of the manufacturing sites (of theStudy 2: The WHO Department of TechnicalCooperation for Essential Drugs and TraditionalMedicine (at WHO Headquarters) and the EssentialDrugs Programme (of the WHO Regional Officefor Africa — AFRO) worked together on analysingthe quality of 440 samples of both prequalified andnon-prequalified ARV products circulating on themarket in Africa. The products were collected byAFRO, together with national government officersand analysed by the Swissmedic Official MedicinesControl Laboratory (OMCL).Results: Of the 440 samples tested, only 13 werefound to have nonconformities, none of which wereconsidered severe. Six products concerned the samemanufacturer and some of the issues related to newpackaging formats. Further ARV product sampleshave been collected in Africa and are being tested.PREQUALIFICATION OF PRODUCTS FOR TBprogramme activities in 2005active pharmaceutical ingredient and the finished product)is organized.Inspection of a CRO is sometimes also necessary.Products submitted for prequalification are often multisourcegenerics. In such cases, therapeutic equivalencewith an innovator (brand-name) product is verified byperforming a bioequivalence study. Such studies aregenerally carried out by an independent CRO, which musttherefore also be inspected and approved.A total of 52 assessment reports — linked to morethan 50 TB products — were written during thenine Copenhagen dossier assessment sessions.Approximately 65 TB products were evaluated forprequalification. Almost 50 TB product dossierswere also reviewed by experts, to assist the GlobalDrug Facility 1 , which is reviewing the quality ofcommonly available TB products that have not yetbeen prequalified.Inspections included: five GMP inspections ofTB finished product manufacturing sites; threeinspections of API manufacturing sites and twoinspections of CROs.By the end of 2004, a total of eight TB productshad been prequalified. However, no TB productswere prequalified during 2005. This was due tocontinued failure of manufacturers to comply withprequalification requirements. Current strategiesfor improving compliance include increasedcommunication with manufacturers — witha focus on the benefits for manufacturers ofprequalification — and rapid provision of feedbackconcerning the quality of their products afterdossier submission.Three inspections of API manufacturers werecarried out, in cooperation with the Division ofthe Certification of Substances, of the EuropeanDirectorate for the Quality of Medicines (EDQM),of the Council of Europe.photo © WHOWHO PREQUALIFICATION PROGRAMME

PROgramme backgroundThe results — positive or negative — of dossierassessments and inspections are communicated carefullyto manufacturers and CROs. This technical feedback(which is provided free of charge) has proved to be ofgreat practical value because it helps manufacturers andCROs to improve the quality of their products and theirclinical studies.Prequalification of NPQCLs follows similar procedures.An NPQCL must respond to an Expression of Interestand submit a laboratory information file for assessment.If the file is approved, the laboratory is then inspectedto verify that its quality control activities are adequatelyrigorous for monitoring medicines quality. NPQCLsare not only inspected but also assisted to reachprequalification status through provision of customizedtechnical guidance and assistance — in the form ofinventory audits — to improve laboratory managementPREQUALIFICATION OF PRODUCTS FORMALARIADuring the nine dossier assessment sessions,73 assessment reports were written, linked to morethan 40 malaria products. An ad hoc team of expertassessors was set up to assess malaria productdossiers during and outside regular sessions, andhas been operational since the second half of 2005.However, only four new malaria product dossierswere submitted in 2005, reflecting continuingdifficulties in this sector regarding provisionof data. (Providing data on malaria products isdifficult owing to the lack of suitable ICH-approvedcomparators. 2 Data on these products thereforehas to be provided as if they were innovatorproducts, which is a challenging task for genericsmanufacturers.) One of the 2005 Copenhagensessions was specifically aimed at addressing thesafety and efficacy elements of submitted malariaproduct dossiers. Six GMP manufacturing-siteinspections and two API manufacturing-siteinspections were conducted.programme activities in 2005and practice. NPQCLs are vital to ongoing quality controlof prequalified products. That is, they check the qualityof medicines circulating on the market. In the case ofmedicines that have previously been prequalified, theycheck that the prequalified medicines continue to complywith internationally determined and agreed standards forpharmaceutical safety, efficacy and quality.Progress on artemisinin-based antimalarialsIn September, WHO experts met to review thecurrent guidelines for prequalifying artemisininbasedantimalarials. The objective was to findmeans of encouraging and enabling greaternumbers of manufacturers to submit their productsfor prequalification, and to meet prequalificationrequirements.The meeting recommended:• preparation of a preclinical pharmacologytoxicologysummary of artemisinin derivativesto help applicants in preparing their dossiersubmissions — a draft was prepared and hassince been finalized• preparation of a model summary of productcharacteristics (SPC 3 ) for artesunate, also toguide applicants in preparing their dossiersubmissions — a draft model is currentlyunder review.These materials will be posted on theprequalification web-site, to encouragemanufacturers to improve the quality of dossiersubmissions for antimalarials.photo © WHOWHO PREQUALIFICATION PROGRAMME

PROgramme backgroundThe dossier assessments and inspections are carried outby a group of qualified, external experts from nationalmedicines regulatory agencies (NMRAs), mostly fromcountries that are members of the PharmaceuticalInspection Cooperation/Scheme. They provide assessmentand inspection support to a core team at WHO headquarters.The Programme actively seeks the participation ofregulatory staff from less well resourced NMRAs inAfrica, Asia, Latin America, and the countries of centraland eastern Europe, in dossier assessment sessions andinspections. Such participation constitutes valuable “onthe-job”training. Additionally, workshops are organized forregulatory staff (including NPQCL staff) and manufacturersto alert them to common problems identified during themanufacture and development of generic medicinesfor HIV/AIDS, TB, malaria. By these means, valuableknowledge on medicines quality, efficacy and safety issuesis transmitted. As a result, the capacity of manufacturersto produce good-quality generic products is increasing,as is the capacity of NMRAs and NPQCLs to monitorpharmaceutical quality.PREQUALIFICATION OF NPQCLsNPQCLs started to be prequalified in 2005. ThreeNPQCLs were prequalified — 2 university-basedlaboratories in South Africa and a laboratory inAlgeria. All are listed on the prequalification web-site.By the end of 2005, more than 15 laboratories hadexpressed interest in gaining approval; and 13 ofthem had submitted a laboratory information file,the first stage of the process. The files were evaluatedand five inventory audits (as a means of guidingNPQCLs on needed improvements to laboratorypractice and management) were carried out.programme activities in 2005ACTIVITIES COVERING ALL PRODUCT GROUPSGuidance on comparator productsA special document to guide manufacturers inthe selection of suitable comparator products 4 forbioequivalence studies was written by experts andpublished on the prequalification website — Noteto applicants on the choice of comparator productsfor the Prequalification Programme. It includeslists of suitable comparators for HIV/AIDS,malaria and TB medicines. The Note will serveas an interim solution until finalization of therevision of Annex 11 of Guidance on the selection ofcomparator pharmaceutical products for equivalenceassessment of interchangeable multi-source (generic)products (published as Technical Report Series,No. 902, 2002) and its publication.Full details of the prequalification procedures andprequalified products can be found at: http://mednet3.who.int/prequal/TRAINING AND HANDS-ON PRACTICERecognizing the importance of capacity buildingthrough training and hands-on practice, theprequalification team organized six workshopson prequalification issues. Participants includedlocal and international medicines manufacturers,local and international medicines regulators,and experts and inspectors involved in dossierassessment, clinical studies, bioequivalence andquality assurance. Most workshops includedgroup sessions with task work. Communicationbetween manufacturers and inspectors was openand collegial, and promoted mutual understandingconcerning quality problems. Feedback on theworkshops has been very positive: they are seen as acatalyst for increasing capacity to ensure medicinesquality. Workshop details are given below.photo © WHOWHO PREQUALIFICATION PROGRAMME

PROgramme backgroundWHO BENEFITS FROM PREQUALIFICATION?People at risk from and/or infected with HIV/AIDS,TB and/or malaria: For HIV/AIDS patients, in particular,scaled-up access to medicines of assured quality isleading to a vastly improved quality of life. It is also helpingto reduce wasted expenditure on substandard medicines,be this at household level for medicines purchasedby individuals and their families, at national level formedicines purchased by central medical stores, or at thelevel of global treatment initiatives. In other words, moreWorkshop 1: MalaysiaFebruary (5 days)Subject: Dossier requirements for TB products(pharmaceutical quality, bioequivalence and GMP).Workshop 2: ChinaFebruary/March (5 days)Subject: Dossier requirements for HIV products(pharmaceutical quality, bioequivalence and GMP).Workshop 3: South AfricaApril and June/July (2 x 5 days)Subject: GMP for inspectors of South Africa’sMedicines Regulatory Authority.programme activities in 2005patients are being treated optimally.National medicines regulatory authorities(NMRAs): In resource-limited settings, in particular,Workshop 4: ChinaMay (9 days)Subject: GMP for inspectors of the State Food and DrugAdministration of the Jiangsu and Zhejiang Provinces.the Prequalification Programme is helping medicinesregulatory staff to increase their technical capacity tomonitor and ensure the quality of medicines, particularlythose for treating HIV/AIDS, TB and malaria. This includesdeveloping greater understanding of: dossier assessmentfor new generic medicines; good manufacturing practice(GMP) adherence and GMP inspection; and how toovercome problems resulting from poor manufacturingWorkshop 5: UkraineOctober (5 days)Subject: Dossier requirements for HIV and TBproducts (pharmaceutical quality, bioequivalenceand GMP).Workshop 6: TanzaniaOctober (5 days)Subject: GMP for inspectors of Tanzania’s Food andDrug Authority.practices. For NMRA Programme participants fromdeveloped countries, the principal benefit is a greaterTraining materials initiativeunderstanding of regulatory problems in resource-poorsettings and problems encountered by pharmaceuticalmanufacturers outside their jurisdictions.The Technical Office for Studies on InternationalCooperation (Office Technique d’Etudes deCoopération Internationales 5 — OTECI) agreed totranslate training material on GMP into French (forcompletion in 2006). The translated material willbe a major contribution to training workshops to beheld in francophone Africa.ADVOCACY AND AWARENESSPrequalification team members took part in morethan 10 meetings in 2005. By presenting andexplaining the Programme’s activities they helpedto maintain awareness and understanding of theneed for and impact of prequalified medicines. Themeetings included:photo © WHO/Sophie Logez• The annual meeting of WHO MedicinesNational Professional Officers (NPOs), inNairobi, in February, which was attended byAfrica-based NPOs, as well as some of theirMinistry of Health counterparts.WHO PREQUALIFICATION PROGRAMME

PROgramme backgroundNational pharmaceutical quality control laboratories(NPQCLs): For functional developing country NPQCLs,benefits include increased capacity to assess the quality ofmedicines samples, not simply for medicines for treatingHIV/AIDS, TB and malaria, but medicines in general.Pharmaceutical manufacturers in developingcountries: The capacity of this very diverse group toproduce medicines of assured quality, efficacy and safetyis being enhanced, in turn reducing reliance on imports,and increasing opportunities for export. Manufacturershave already been assisted in improving the qualityof their dossier submission. An increased number ofgeneric medicines manufacturers now routinely submitdossiers that include sufficient detail regarding proofof safety, efficacy and quality. In short, the Programmeoffers manufacturers a tremendous opportunity to obtain• The annual Technical Briefing Seminar onEssential Medicines Policies, in September,in Geneva, for a selected group of 35 corenationals representing ministries of health,regulatory agencies, professional pharmaceuticalassociations and nongovernmental organizations(NGOs), as well as WHO field staff.• The African Medicines Regulatory AuthoritiesConference, in Addis Ababa, Ethiopia, inOctober/November.• The annual meeting organized by AFSSAPS, inParis, in November, on public health problems(especially those related to HIV/AIDS) faced bysub-Saharan French-speaking African countries.• Roundtable (Mieux s’engager dans la luttecontre le sida, le paludisme et la tuberculose)organized by ReMed (Réseau Médicaments etDéveloppement), a French NGO, in Paris, inNovember.programme activities in 2005technical guidance free of charge, that is of the highestcalibre and that might otherwise be unavailable to them.National disease control programmes and globalhealth initiatives: Prequalification not only reducesthe risk of expenditure on poor-quality, ineffective orcounterfeit medicines, but is also extending the rangeof suppliers of good-quality medicines. Given extensionof treatment to unprecedented levels, this is critical.• The Center for Drug Evaluation and ResearchForum for International Drug RegulatoryAuthorities held at US FDA offices in Rockville,USA, in September. Discussions took placeon collaboration between the PrequalificationProgramme and the US FDA, and on the FDA’stentative approval process for generic ARVs.Additionally, Programme staff briefed national andinternational journalists on medicines quality issues,helping to maintain public awareness of the neednot only to increase access to essential medicines butalso to improve medicines quality globally.TRANSPARENCY ABOUT MEDICINES QUALITYThe Programme includes a focus on transparency,especially regarding quality issues relating togeneric medicines. Information collected and resultsobtained during assessments and inspections are(subject to confidentiality requirements) madepublicly available through WHO prequalificationweb-pages and published reports.photo © International Herald TribuneWHO Public Assessment and Inspection Reportsare a major means of communication. (In 2004,the World Health Assembly requested that WHO’sprequalification activities be made more transparent,including making assessment reports and inspectionreports publicly available.) The prequalification teamhas created a standardized format for the WHOPublic Assessment Report (WHOPAR). WHOPARsare posted on the prequalification website. TheWHO PREQUALIFICATION PROGRAMME

PROgramme backgroundAccess to ARV therapy is set to expand ten-fold by 2010, basedon the commitment made by the Group of Eight in 2005, andcurrent funding commitments for treatment of malaria withartemisinin-based combination treatment is driving a onehundred-fold increase. Without quality medicine supplies,these increases will be impossible.VALUE FOR MONEYThe Prequalification Programme is helping to ensure thatdonor funds are spent on good-quality medicines and achievemaximum impact. Indeed, the Global Fund to Fight AIDS,TB and Malaria (GFATM) now stipulates that any single- orlimited-source pharmaceuticals procured with GFATMfunds must have been prequalified by WHO. Prequalificationof products in turn puts pressure on manufacturers tobring prices down, which also serves to optimize use ofdonor resources.web-site includes guidance for manufacturersregarding these reports and information on how thereports are compiled by the prequalification team.(When submitting a product dossier for assessment,manufacturers must include specified documentationfor inclusion in the WHOPAR that will later becompiled on their product.)A standardized format was also developed forWHO Public Inspection Reports (WHOPIRS),which summarizes the technical issues covered byan inspection. Completed WHOPIRs are postedon the prequalification web-site and serve as usefulreference material for anyone interested in themedicines prequalification process.programme activities in 2005NEW COLLABORATIONCopenhagen HIV ProgrammeIn 2005 the prequalification team launched anew collaboration with the Copenhagen HIVProgramme (CHIP), based in Denmark’s HvidovreUniversity Hospital. The CHIP collaborationwill promote consistency of clinical informationabout ARV products, as well as help to reduce thetimeline for provision of acceptable and usefulSPCs. Activities will focus on reviewing safety andefficacy information relating to ARV products andcontained in WHOPARs. Under the collaboration,a standardized text on safety and efficacy for APIsand API combinations has already been drawn up,to be used as a basis for developing SPC texts.The ultimate goal is generation of up-to-datemedical information about prequalified ARVs, tobe included with the products, to help ensure theirappropriate and effective use.US FDA and other regulatory authoritiesA number of HIV products approved or tentativelyapproved by the US FDA were recently added tothe list of products prequalified by WHO. Theseadditions relied on the scientific assessment andinspections already conducted by the US FDA.Relevant information was exchanged, in accordancewith a confidentiality agreement signed by the twoorganizations in 2005.photo © WHO/Hans HogerzeilCollaboration is also being developed withthe European Commission and EuropeanMedicines Evaluation Agency. In December,the Prequalification Programme was invited toparticipate in the GCP 6 Inspection Services GroupMeeting. The aim was to explore more effectiveWHO PREQUALIFICATION PROGRAMME

PROgramme backgroundThe expansion of ARV therapy in Africa provides ampleillustration of the health impact resulting from the financialsavings generated by the Programme. Between June 2004and June 2005, coverage increased by 350,000 people, tohalf a million people living with HIV. Most were enrolled toone of WHO’s recommended first-line regimens. On average,these regimens are available for US$ 560 per patient peryear when purchased from innovator companies. Genericcompanies, whose products have been widely available onlyas a result of WHO prequalification (and whose availabilityaccords with national law and donor policy), provide theseregimens for less than US$ 190 per patient per year.Assuming that 80% of those enrolled in Africa in the last yearbegan treatment with these regimens, the value of usingprequalified generic products can be quantified as more thanUS$ 100 million. (This is the difference in total cost of usingthese medicines rather than comparable innovator productsfor 280,000 patient-years.) This sum, when reinvested,provides an additional 560,000 patients with access to oneyear of treatment.ways of sharing and exchanging inspection-relatedinformation, in order to benefit from each other’swork and to avoid duplication.A confidentiality agreement similar to the onewith the US FDA is being developed to facilitatecooperation between the PrequalificationProgramme and Health Canada’s Health Productsand Food Branch.PUBLICATIONS AND INFORMATIONThe prequalification website (http://mednet3.who.int/prequal/) was updated frequently in2005. Newly prequalified products and NPQCLswere posted, as were new or revised guidancedocuments, together with WHOPIRs, WHOPARsand workshop training materials.programme activities in 2005During 2005, 11 WHOPARs for specific productsand 15 WHOPIRs covering all types of inspections,were posted. More than 10 additional WHOPARswill be published in early 2006 for other productsprequalified in 2005.The Prequalification Programme also publishedthe three articles listed below. The first two articlesdescribe general prequalification principles andprocedures, while the third outlines ongoing qualitymonitoring of antiretroviral medicines.1. Prequalification of medicines. WHO DrugInformation, 2005, 19:1.2. WHO and its Prequalification Programme:an overview. WHO Pharmaceuticals Newsletter,2005, No. 2.3. Dekker TG, van Zyl AJ, Gross O, Tasevska I,Stahl M, Rabouhans ML, Rägo L. Ongoingmonitoring of antiretroviral products as part ofWHO’s Prequalification Programme. Journal ofGeneric Medicines, 2006, 3(2):96–105.Guidance documentsRevised versions of three guidance documents wereposted on the prequalification web-site:photo © WHO/Viktor Suvorov• Guidance on submission of documentationfor prequalification of innovator finishedpharmaceutical products (FPPs) used in thetreatment of HIV/AIDS, malaria and tuberculosisand approved by drug regulatory authoritites(DRAs) in the International Conference ofHarmonisation (ICH) region and associatedcountries, including among others the EU, Japanand USAWHO 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