WHO Drug Information Vol. 25, No. 2, 2011
WHO Drug Information Vol. 25, No. 2, 2011
WHO Drug Information Vol. 25, No. 2, 2011
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
<strong>WHO</strong> <strong>Drug</strong> <strong>Information</strong> <strong>Vol</strong>. <strong>25</strong>, <strong>No</strong>. 2, <strong>2011</strong><strong>WHO</strong> Prequalification ofMedicines ProgrammeFacts and figures for 2010Evaluation of medicines by the <strong>WHO</strong>Prequalification of Medicines Programme(PQP) includes assessment of data andinformation on safety, efficacy and quality.Inspections are performed to assesscompliance with good manufacturingpractices (GMP) and include manufacturersof selected active pharmaceuticalingredients (API) and clinical sites.Clinical sites, including contract researchorganizations (CROs), are also inspectedto verify bio-equivalence with goodlaboratory practices and good clinicalpractices.Thirty-six products were prequalified in2010, of which 30 were generics. At theend of 2010, the <strong>WHO</strong> list of prequalifiedmedicines totalled <strong>25</strong>2 products manufacturedin 20 countries. <strong>WHO</strong> prequalification“firsts” included artesunate powderfor injection (which was the first prequalifiedsterile product made in China); thefirst combination tenofovir disoproxilfumarate/lamivudine and the first genericemtricitabine.Six medicines quality control laboratories(QCLs) were also prequalified: one inBolivia, one in Canada, one in Peru, twoin Ukraine and one in Uruguay. At the endof 2010, a total of 17 QCLs had beenprequalified and a further 30 were workingtowards becoming prequalified.Invitations to manufacturers to submit anexpression of interest (EOI) for productevaluation were issued for anti-TB medicines,HIV/AIDS-related care and treatmentproducts, and reproductive healthproducts. The new invitations incorporateadditional products and/or take intoaccount revisions made to <strong>WHO</strong> treatmentguidelines. Additionally, the firstinvitation to manufacturers of activepharmaceutical ingredients (APIs) wasissued in October 2010, marking thelaunch of <strong>WHO</strong> prequalification of APIs.(A second, expanded invitation to APImanufacturers to submit an EOI wasissued in March <strong>2011</strong>.) It is expected thattime taken to reach prequalification will beshorter for finished pharmaceuticalproducts (FPPs) that are manufacturedusing <strong>WHO</strong>-prequalified APIs, than forFPPs that are manufactured using APIsthat have not previously been evaluatedby <strong>WHO</strong> PQP.Assessment activitiesIn 2010, 51 dossiers were submitted and53 dossiers (two of which were receivedin late 2009) were accepted for evaluation.Nearly 1000 assessment reportswere produced. PQP also assessednearly 600 variations submitted bymanufacturers of prequalified products.The assessment sessions held in Copenhagen,Denmark, include a trainingcomponent which is enabling a growingnumber of developing country assessorsto acquire stringent regulatory expertise.The Copenhagen sessions also incorporatetechnical consultations so thatapplicants can discuss technical issuesrelating to their dossiers with assessors.The consultations benefit from the presenceof a range of assessors with considerableassessment experience.A new collaborative procedure for facilitatingregistration of prequalified medicinesin the East African Community (EAC) waspiloted. The overall aim was to identify aframework, for <strong>WHO</strong>-EAC, for jointevaluation and approval of dossiers and101
Change language