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

COMPONENTS OF THE STRATEGY | 91Challenges remainingThere is an urgent need to establish internationalquality specifications for new medicines forHIV/AIDS, TB, and malaria in order to assistprocurement by UN and other agencies for useon a wide scale in developing countries. This isa major undertaking involving many partners,including manufacturers, national and regionalpharmacopoeia commissions, and collaboratinglaboratories. At the same time, there is a needto assess whether the more stringent productspecifications resulting from the introduction bythe International Conference on Harmonization ofRequirements for Pharmaceuticals for Human Use(ICH) of certain quality guidelines will produceadditional public health benefits. In addition,there is a continuing need to complement andupdate existing quality specifications.Meeting the challenges 2004-2007Over the next four years WHO will:> produce quality control specifications andreference materials and appropriate adviceto national quality control laboratories,especially for new medicines for public healthpriority diseases such as ARVs for HIV/AIDS.> work closely with the WHO CollaboratingCentre for Chemical Reference Substancesin Sweden, and with other centres whichvalidate the methods and challenge thespecifications developed with products ontheir national market.> support closer collaboration betweenpharmacopoeias and national regulatoryauthorities to meet the challenge ofassuring the quality of medicines tradedinternationally.OUTCOME INDICATORS1999 2003 2007No. and types of pharmaceutical specifications andreference materials developed by WHO HQ#REPORTING % TARGET#REPORTING % TARGETna na 105 96 na 50