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

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WHO MEDICINES STRATEGY 2004-2007 | 50EO 2.2Safety, efficacy, and quality ofTM/CAM enhanced throughexpanding the knowledge base onthe safety, efficacy, and quality ofTM/CAM, and providing guidanceon regulation and quality assurancestandardsRationaleTM/CAM practices have evolved within differentcultures in different regions. As a result, therehas been no parallel development of standardsand methods, either national or international, forevaluating them. This is especially true of herbalmedicines, the efficacy and quality of which canbe influenced by numerous factors. The regulationand registration of herbal medicines are thekey measures to ensure their safety, quality, andefficacy.ProgressOver the past four years, WHO has developed aseries of technical guidelines to support countriesin establishing the regulations for ensuring thesafety, efficacy, and quality of TM therapies andproducts. In addition, seven regional trainingworkshops have been held in five WHO regions(covering 52 countries) to help strengthen nationalcapacity in the regulation of herbal medicines.Four WHO Regions (AFRO, AMRO, EMRO,and SEARO) developed regional minimumrequirements for registration of herbal medicinesbased on WHO technical guidelines.According to the WHO global survey on nationalpolicy on TM/CAM in 2002-2003, 82 countriescurrently regulate herbal medicines, comparedwith 60 countries in 1995-99, and 78 countrieshave a registration system for herbal medicines.In 1999, a WHO report on malaria in Africarevealed that over 60 % of sick children withfevers were treated with herbs at home and bytraditional health practitioners – often the onlyform of treatment they received. However, thesafety and efficacy of these antimalarial herbshave not been fully understood. In response,in 2000 WHO initiated a pilot project on thecontribution of traditional medicine in combatingmalaria and has been supporting national clinicalstudies on antimalarial herbal medicines in threeAfrican countries. A mid-term review of thestudies was completed in 2002.WHO has collected evidence-based informationon TM/CAM such as analysis and review ofacupuncture based on controlled clinical trials,published in 2002 in cooperation with itscollaborating centres and other research institutes.In 2003, WHO also supported China in theevaluation of research in integrated treatment forSARS cases.In addition, in 2003 WHO developed guidelineson Good Agricultural and Collection Practices(GACP) for medicinal plants and initiated thedevelopment of guidelines on assessing the safetyof herbal medicines, with particular reference toresidues and contaminants.ChallengesThe quantity and quality of the safety and efficacydata on traditional medicine are far from sufficientto meet the criteria needed to support its useworldwide. One of the reasons for the shortage ofresearch data is the lack of financial incentives asmost of these products are not covered by patents.Scientifically justified and accepted globalresearch methodology for evaluating the efficacyand safety of traditional medicine is a majorchallenge.Although there has been a recent increase inthe number of governments that regulate herbalmedicines, national regulation and registration ofherbal medicines vary from country to country.Where herbal medicines are regulated, they arecategorized in different ways (e.g. prescriptionmedicines, dietary supplements, health food).
Number of Member Statesadopting policyCOMPONENTS OF THE STRATEGY | 51However, a group of herbal products categorizedother than as medicines, may also exist withinthe same country. Moreover, the regulatory statusof a particular herbal product varies in differentcountries. Regulatory status also determines theaccess or distribution route of these products. Anadditional challenge is the increasing popularityof herbal products categorized other than asmedicines or foods. There is an increased risk ofmedicine-related adverse events, due to lack ofregulation, weaker quality control systems, andloose distribution channels (including mail orderand Internet sales).Figure 11:Growth of regulation of herbal medicines80706050403020Before 1990 1990-1994 1995-1999 2000-2003Time PeriodSource: Interim summary analysis of WHO global survey onnational policy on traditional medicine and complementary/alternative medicine, 2002-2003Meeting the challenges 2004-2007Over the next four years WHO will:> publish global guidelines on the regulation ofherbal medicines (2004).> continue to support Member States in theirefforts to establish effective regulatory systemsfor registration and quality assurance of herbalmedicines by: organizing training workshopsto strengthen national capacity on theseissues; and supporting efforts to developnational lists of medicinal plants together withinformation on their safety.> increase efforts to improve access to TM/CAMand expand the information available on thesafety, efficacy, and quality of TM/CAM by:conducting technical reviews of researchon use of TM/CAM therapies for prevention,treatment, and management of commondiseases and conditions; expanding selectivesupport for clinical research into use of TM/CAM for priority public health problems suchas malaria, HIV/AIDS, and common diseases;and collating and exchanging accurateinformation.> establish criteria for evidence-based data onthe efficacy, safety, and quality of TM/CAMtherapies, in order to facilitate research.OUTCOME INDICATORS1999 2003 2007#REPORTING % TARGET#REPORTING % TARGETNo. of countries regulating herbal medicines d 48 na na 82/127 d 65 d 75%
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REFERENCES | 1471Annual report 2000
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REFERENCES | 14912 th Model List of
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