WHO Drug Information Vol. 24, No. 4, 2010

More documents

Recommendations

Info

World Health OrganizationWHO Drug Information Vol. 24, No. 4, 2010WHO Drug InformationDigital Library,e-mail table of contentsand subscriptionsavailable at:http://www.who.int/druginformation292
WHO Drug Information Vol. 24, No. 4, 2010WHO PrequalificationProgrammesWHO Prequalification of Medicines Programme:survey of service quality provided to manufacturersEstablished in 2001, the Prequalification of Medicines Programme (PQP) is a serviceprovided by the World Health Organization (WHO) to facilitate access to quality medicinesfor treating priority diseases. In order to be prequalified, medicines must meetWHO-specified standards for quality, safety and efficacy. PQP is supported by variousUnited Nations agencies (e.g., UNAIDS, UNICEF, UNFPA) and the World Bank.WHO prequalification of medicines is a multi-step process whereby a manufacturersubmits extensive information that is then evaluated by a WHO assessment teamwith respect to product quality, safety and efficacy, site(s) of manufacture and anyclinical studies that may have been carried out during development. Products thatsuccessfully pass PQP evaluation are listed on the WHO List of Prequalified MedicinalProducts (see: http://www.who.int/prequal). This list provides UN agencies with asingle source of reference for quality-assured priority medicines and is also used bya variety of entities, both country-specific and international, that purchase medicinesin bulk quantities.The Prequalification of Medicines Programme has conducted a comprehensive surveyamong pharmaceutical manufacturers to assess its level of service. PQP assessmentand inspection activities reflect those carried out by national regulatoryauthorities before granting marketing authorization (registration) for a medicine. Theassessment review was therefore designed to maximize the diagnostic capability ofthe survey: to measure both the level of service provided by PQP and the levels ofservice expected from regulatory authorities by manufacturers. The survey includeditems relevant to the assessment of product dossiers and on-site inspections of manufacturingfacilities in a way that separated service design (the service process) fromservice delivery (or the “people” aspects of service). The results of this survey providedirection for improvements to the current Programme and have implications forfuture strategic development.The surveyIn administering the Prequalification ofMedicines Programme (PQP), WHOinteracts with a number of stakeholdergroups and organizations whose objectivesare dependent upon, or related to,WHO prequalification of medicines:manufacturers, government agencies(including national and regional medicinesregulatory authorities) and donororganizations. In 2009, one such donororganization recommended that WHOundertake a process optimization reviewwith respect to PQP – an exercise thatwould include feedback from manufacturerswith experience of WHO prequalificationof medicines.To provide guidance in developing asurvey of manufacturers, implementingthe survey and analysing the results,PQP retained the services of a marketresearch consulting company, Interclarity293
Page 1: WHO Drug Information Vol. 24, No. 4
Page 5 and 6: WHO Drug Information Vol. 24, No. 4
Page 53 and 54:
WHO Drug Information Vol. 24, No. 4
Page 55 and 56:
Page 57 and 58:
Page 59 and 60:
Page 61 and 62:
WHO Drug Information, Vol. 24, No.
Page 63 and 64:
Page 65 and 66:
Page 67 and 68:
Page 69 and 70:
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
Page 79 and 80:
Page 81 and 82:
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
Page 93 and 94:
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
Page 127 and 128:
show all

WHO Drug Information Vol. 24, No. 4, 2010

Create successful ePaper yourself

Delete template?

Save as template?