WHO 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