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

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WHO MEDICINES STRATEGY 2004-2007 | 108EO 6.7Safety of new priority andneglected medicines enhancedthrough training workshops andincreased capacity to assess safetyissuesRationaleWith all newly registered products there is limitedexperience of large-scale operational use or ofthe safety of these medicines when used amongspecial population groups, such as infants,pregnant women, and people suffering frommalnutrition or HIV/AIDS. This is a particularproblem for new medicines for priority andneglected diseases since these are normallyintroduced with some urgency and there is aneed to ensure that this is done within acceptablestandards of safety assessment. The urgency ofthis problem is exemplified by current efforts toprovide ARVs to 3 million people by 2005 — foruse in settings which differ from those where mostof the safety studies have been carried out.ProgressA training course on pharmacovigilancewas held in Zambia in 2002, involving fiveAfrican countries which are introducing ACTfor malaria in response to increasing levels ofresistance to antimalarials (Burundi, DemocraticRepublic of Congo, Mozambique, Zambia,and Zanzibar). The course focused on basicmethods and skills for drug safety monitoring,with the aim of introducing a common system ofpharmacovigilance of new antimalarial treatmentsin each country, with access to the WHOdatabase and to international expertise. Similarcourses are planned for other diseases includingHIV/AIDS.Challenges remainingA major challenge is the need to ensure theintegration of this work throughout WHOprogrammes. The Programme to EliminateLymphatic Filariasis, for example, has introduceda system for monitoring adverse effects of thedrugs used in mass populations. Other diseaseprogrammes need to be aware of the needfor high-level coordination of these efforts.Meanwhile, as efforts get under way to scale upaccess to ARVs in developing countries, there isa need to develop plans for pilot programmesto monitor the safety of these medicines amonggroups suffering from malnutrition or affected bymore than one disease. Partnerships with otherorganizations are needed to strengthen WHO’swork in this critical area.Meeting the challenges 2004-2007Over the next four years WHO will:> increase efforts to provide training courses forpharmacovigilance in the area of neglecteddiseases and continue to raise awareness ofthis problem.> support national initiatives to conduct postmarketingsurveillance of medicines such asARVs and antimalarials.> train regulators and health care professionalsin safety monitoring, with a special focus onnew combination medicines for HIV/AIDS,TB, and malaria, and other priority publichealth diseases.OUTCOME INDICATORS1999 2003 2007No. of countries participating in training programmesfor introducing new therapies for priority and neglecteddiseases, e.g. malaria and AIDS#REPORTING % TARGET#REPORTING % TARGET0 na na 7 na 20
COMPONENTS OF THE STRATEGY | 109EO 6.8Regulatory harmonizationmonitored and promoted asappropriate, and networkinginitiatives developed, to facilitateand improve regulatory processes incountriesRationaleHarmonization of technical requirements forregistration of medicines can contribute to publichealth by improving access to safe, effective, andgood-quality pharmaceutical products. It can alsofacilitate the development of fair and transparentregulatory processes, improve internationalcollaboration, reduce duplication of work bydifferent regulatory agencies, and facilitate tradeand competition. The harmonization initiatives,whether regional or sub-regional, are ongoingin all WHO regions. The major focus of manyof those initiatives is to first harmonize basicregulatory requirements for generic medicines.The ICH, an initiative started by Europe, Japan,and the United States in 1990, has been focusingon establishing harmonized requirements toevaluate the quality, safety, and efficacy of newinnovative drugs, thereby avoiding the necessityto duplicate many time-consuming and expensivetest procedures. As a result, the time spent onregulatory approval of new drugs has beenshortening, and marketing of these products takesplace internationally with minimal delay for thepatients. By 2003, the ICH regions have largelyharmonized regulatory requirements for thequality, safety, and efficacy of new drugs.have finalized their regulatory harmonizationand are expected to join the European Unionin 2004. In the Americas, the Pan-AmericanNetwork for Drug Regulatory Harmonizationhas made considerable progress since its firstSteering Committee meeting in 2000 in PuertoRico. Other WHO-supported initiatives includethe ASEAN Pharmaceutical Harmonizationand harmonization amongst Southern AfricanDevelopment Community (SADC) countries.The non-ICH harmonization initiatives areemphasizing the importance of training ofregulators as an important vehicle to driveharmonization forward.Challenges remainingThe huge gaps in existing regulatory capacitiesare hindering harmonization. Progress has beenslowed by limited resources and lack of politicalwill. The regulatory approval of generic drugswhich are more affordable for patients remainslargely unharmonized, paradoxically more soin countries where health care systems relyheavily on the use of generic drugs. Regulatoryassessment of products by national authorities,especially in the case of new medicines, oftengives limited added value to the work alreadydone by other regulatory authorities. The potentialfor financial savings through mutual recognitionof regulatory assessments remains underestimated.There is also a tendency to adopt sophisticatedtechnical requirements before basic measureshave been put in place to protect public healthand ensure the quality (e.g. basic registrationrequirements, GMP, and supply chain inspection)of medicines.ProgressWHO/EURO actively supported the establishmentof the Collaboration Agreement of DrugRegulatory Authorities in European UnionAssociated Countries (CADREAC), which hasmade rapid progress since its first Annual Meetingin Sofia in 1997. Ten CADREAC countries
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