WHO Drug Information Vol. 25, No. 2, 2011

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WHO Prequalification of Medicines ProgrammeWHO Drug Information Vol. 25, No. 2, 2011inspections of medicine manufacturingsites, and to ensure that these assessmentsare integrated into national regulatorydecision-making. Two assessorseach from three EAC countries (Kenya,Tanzania and Uganda) and six WHOassessors jointly assessed two productdossiers submitted by a single manufacturer.The dossiers were submitted inparallel, and with identical content, toeach participating EAC country and toPQP. The products were both prequalified:HA488 (abacavir, dispersible tablets60 mg) in August 2010 and TB217(amikacin, injection 500 mg/2 ml) inJanuary 2011. For the manufacturer, theprincipal benefit of this joint assessmentwas that once the products had beenjointly assessed and approved by WHO-EAC, they were granted immediateaccess to the markets of each of thecountries that had participated in the jointassessment. For the regulators involved,such joint assessment contributes toharmonization of regulatory requirementsat regional level. PQP is hoping to usethe same model for assessing selected,technically complex, high-priority products.Several partners and stakeholderssee joint assessment as an effectivemeans of speeding up access to muchneeded products.InspectionsPQP inspectors carried out 59 inspectionsin 18 countries: 38 of finishedpharmaceutical product manufacturingsites; five of API manufacturing sites;seven of CROs and nine of pharmaceuticalQCLs. (Inspections were carried outmostly in India and in China, but also inAlgeria, Belgium, Bolivia, Egypt, France,Iran, Kenya, Morocco, the Netherlands,Peru, Russia, South Africa, Tanzania,Uganda, Uruguay, the United States andZimbabwe.)A new collaborative procedure for jointinspections was initiated at the beginningof 2010. A secure web site has beenestablished for the sharing of inspectionplans, arranging of joint inspections, andsharing of information and inspectionreports, with recognition by participatingEAC parties and PQP. This will be furtherexplored and possibly expanded. Jointinspections are planned for 2011 in anattempt to prevent duplication of inspections.Inspection reports will be shared bythe parties following the inspection. It ishoped that the outcome of the inspectionwill be accepted by all participatinginspectorates. PQP continues to invitelocal medicines regulatory authority staffor observers to participate in inspections.The risk assessment procedure foridentifying which API manufacturing sitesshould be inspected has been completedfor substances used to manufactureproducts for the treatment of malaria andTB. It is planned to expand this riskassessment to APIs used in products forthe treatment of HIV/AIDS.Advice and assistancePQP continues to respond to manufacturers’request for assistance concerningissues relating to, for example, bioequivalencestudy protocols and choice ofcomparator products.PQP continues to provide technicalassistance to manufacturers and nationalQCLs that aims at resolving specificpractical problems related to GMP, goodpractices for QCLs and/or meetingmedicines regulatory requirements.Assistance is given in the form of anaudit, advice on development of animprovement plan, and training in technicalor regulatory areas. Follow-up missionsare also organized to supportimplementation of improvement plans. In2010, PQP organized 22 technical assistancemissions to pharmaceutical manufacturersin four countries (Argentina,China, India and Indonesia) and 10technical assistance missions to nationalQCLs (in Argentina, Brazil, Burkina Faso,China, Egypt, Jamaica, Panama, Peruand Yemen).102
WHO Drug Information Vol. 25, No. 2, 2011WHO Prequalification of Medicines ProgrammeTraining and hands-on practice remaincrucial to capacity building. PQP organized,co-organized or supported 23training courses. Training on general orspecific technical issues was given tomanufacturers, and to MRA and QCLstaff, as well as an introduction and/orupdate on PQP requirements and services.Training included group sessions aswell as discussion sessions with membersof assessment or inspection teamsworking with PQP. In 2010, these workshopsinvolved more than 1200 participantsrepresenting regulatory authorities,pharmaceutical manufacturers and QCLstaff.Testing of medicines qualityWhen implementing sampling and testingprojects PQP evaluates specifically thequality of WHO-prequalified products. Ina study of the quality of antimalarials,concluded in 2010, the quality of WHOprequalifiedproducts far exceeded that ofnon-WHO-prequalified products. (Lessthan 4% of WHO-prequalified artemetherlumefantrineand artesunate-amodiaquinesamples failed to comply with internationalquality standards, whereas thefailure rate reached 60% for non-WHOprequalifiedsamples of the same composition.)Similarly, a survey of the quality ofanti-TB medicines conducted in 2009/2010 in Armenia, Azerbaijan, Belarus,Kazakhstan, Ukraine and Uzbekistanshowed that all prequalified productssampled and containing isoniazid/rifampicincomplied with internationalquality standards.Norms and standards underpinning orrelevant to WHO prequalificationactivitiesThe Forty-fifth meeting of the WHOExpert Committee on Specifications forPharmaceutical Preparations adoptedfive monographs for HIV and relatedconditions, four monographs for antimalarialmedicines, six monographs forantituberculosis medicines, two monographsfor influenza-specific antiviralmedicines and one for a reproductivehealth product. The Committee alsoadopted a number of new or revisedguidelines and procedures of directrelevance to PQP’s activities.Improving PQP servicesThe results of a survey of manufacturersprovided further information for developinggreater “client” focus. Based on thesurvey results, PQP staff worked onimprovements to the Programme, someof which have already been implemented.For example, raising awareness of theopportunity for manufacturers to meetand consult with PQP assessors, clarifyingprocedure for resolving disagreementssurrounding questions raisedduring the assessment of product dossiers— and some of which (e.g., reducingthe time taken to review and reply toapplicants during the dossier assessmentprocess, providing the same assessorsthroughout the assessment process for aproduct dossier) depend upon completionof other activities (e.g., finalization ofPQP’s new information managementsystem). Others — for example, theperceived greater stringency of WHOGMP requirements — will require furtherdiscussion with manufacturers.Benefits to manufacturersIn 2010, PQP initiated a study to help itdescribe and quantify the potentialbenefits to manufacturers of having aproduct or products prequalified by WHO.PQP will use the results to develop a“business case for participation in WHOmedicines prequalification” for presentationto manufacturers.Further information on the WHO Prequalificationof Medicines Programme, includingthe full list of medicines prequalifiedby WHO can be found at: http://www.who.int/prequal.103
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WHO Drug Information Vol. 25, No. 2, 2011

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