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

COMPONENTS OF THE STRATEGY | 101ChallengesThree types of common imbalance have beenidentified in regulatory practice:> much more time is assigned to premarketingassessment than to post-marketingsurveillance> while product registration is considered amajor responsibility by all the drug regulatoryauthorities, the regulation of drug distributionchannels and information does not enjoy thesame level of attention> in many countries, GMP inspection receivesmore attention and resources than inspectionof distribution channels. 54Meeting the challenges 2004-2007Over the next four years WHO will:> promote implementation of good practice byproviding necessary guidelines, tools, andtechnical assistance> continue to help Member States to assessregulatory capacity and improve regulatoryperformance by capacity building> continue to pursue the external qualityassessment scheme for medicines controllaboratories in all six WHO regions.The quality of products in the market is at riskif regulators and those being regulated fail toapply and monitor principles of good practice inproduction, supply and distribution of medicines,and post-marketing surveillance.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries with basic quality assurance procedures 95/122 78% 80% 111/137 81% 85%