who medicines strategy - libdoc.who.int - World Health Organization

WHO MEDICINES STRATEGY 2004-2007 | 100EO 6.3Good practices in medicineregulation and quality assurancesystems to ensure that qualityis maintained in clinical trials,production, supply and distribution,and post-marketing surveillanceRationaleEssential tools (standards, norms, guidelines)and guidance for good regulatory and qualityassurance practices are widely available,but need to be constantly updated. Somegood practice guidelines, such as GMP andGood Clinical Practice (GCP) guidelines, arenormative documents. Others, like GoodRegulatory Practices, may be of more generalnature and oriented to improving the overallperformance of medicines regulatory agencies.Proper implementation of these regulatory andquality assurance tools according to locallyestablished standard operating procedures isessential as a quality management step for properimplementation of regulation, and to ensurethat the medicines used are safe, effective, andof good quality. The success of regulation isdependent not only on the regulators but alsoon the full compliance of those being regulated(manufacturers and distributors).ProgressAdditional guidelines and tools have beendeveloped, such as new GMP training modulesfor validation, water, heating, ventilation, andair conditioning systems. An external qualityassurance assessment scheme for national andregional quality control laboratories has beencontinued in all six WHO regions, involving 36laboratories. In addition, WHO has developed atool for reviewing national medicine regulatorycapacity, including implementation of GMPguidelines. The review is designed to help bothWHO and the concerned national authoritiesto identify priority areas for capacity building,technical advice, and support. This collaborativework has enabled assessments to be carriedout in a number of countries in order to identifyweaknesses in national regulatory authoritiesand action needed to strengthen capacity.The experience accumulated through thiscollaborative work has helped further refine thedata collection tools and the methodology of thereviews.