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

WHO MEDICINES STRATEGY 2004-2007 | 86EO 5.1Pharmaceutical norms, standardsand guidelines developed orupdated to promote good practicein quality assurance and regulatorymattersRationaleExisting WHO pharmaceutical norms, standards,and guidelines have to be continually updatedto keep pace with advances in pharmaceuticalscience and technology. Today, as efforts getunder way to scale up access to quality essentialmedicines in developing countries, there is anurgent need for WHO to further strengthen thedevelopment of international standards andguidelines on the assessment of multi-sourcegeneric products.In addition, the continuing sale of substandardand counterfeit medicines in some countrieshas highlighted the need for internationalagreements in order to strengthen existingpreventive measures. Elsewhere, increasing tradeand commerce, and the supply of life-savingmedicines by both private and public parties,require new approaches to quality assurance atthe international, regional, and national level.The statutory instruments, advice, andrecommendations provided by the WHO ExpertCommittee on Specifications for PharmaceuticalPreparations can help national authorities,especially national drug regulatory authoritiesand procurement agencies, to combat problemssuch as the production, distribution, and sale ofsubstandard and counterfeit medicines, financialwaste, and the emergence of resistance tomedicines for priority infectious diseases.ProgressWHO has helped raise awareness of the needfor regulatory measures covering the safety ofand trade in starting materials, including activepharmaceutical ingredients and excipients,and the implementation of GMP. In responseto a Resolution of the World Health Assembly(WHA52.19) and recommendations made invarious fora, including the 10 th InternationalConference of Drug Regulatory Authorities, theExpert Committee has adopted new mechanismsfor the control and safe trade of starting materialsfor pharmaceuticals, for action by governments,manufacturers, traders and brokers: (1) GoodTrade and Distribution Practices (GTDP); and (2)Pharmaceutical Starting Materials CertificationScheme (SMACS). Member States are beingencouraged to participate in a pilot phase.The Expert Committee has updated widely usedexisting WHO guidelines on GMP and addedspecific texts such as Guidelines on GoodManufacturing Practices for RadiopharmaceuticalProducts and the Model Certificate of GoodManufacturing Practices.A series of guidance texts have been adoptedby the Expert Committee in relation to theprequalification of suppliers of medicines for HIV/AIDS, TB, and malaria, including:> Procedure for assessing the acceptability, inprinciple, of pharmaceutical products forpurchase by UN agencies> Procedure for assessing the acceptability, inprinciple, of quality control laboratories foruse by UN agencies.