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Herbal regulation

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Herbal regulation

  1. 1. Guidelines for the regulation ofherbal medicinesEuropeUnion
  2. 2. Guidelines for the regulationOf herbal medicinesEurope UnionPost-marketingsurveillanceProductsfromforeigncountriesCombinationproductsIndividualsupplyFurtherdevelopedproductsESCOP& WHOmonographsGMP &QualitycontrolAdvertising,distribution& retail saleClassificationDocumentationof quality,safety& efficacySimplifiedproofof efficacyTheregulation ofFunctionalFoods&NutraceuticalsDefinitionDifferencesbetweenMemberStatesGuideline ‘Quality of Herbal MedicinalProducts’ includes plants, parts of plants &their preparations, mostly presented withtherapeutic or prophylactic claims
  3. 3. 7- The regulation ofFunctional Foods& NutraceuticalsPackagingNutrition labelingLabellingFood Labelling8- IndividualsupplyHerbal medicinal products are madeup and/or supplied to individual patientsfollowing a 1-1consultation betweenpatient and practitioner.A specific situation exists in the United Kingdom,where a practitioner, accordingto Section 12 of the Medicines Act 1968may supply products to acustomer without a licence.9- Products fromforeign countriesControl of rawmaterials or crude drugs, particularlyfor products that enter the market asfoodstuffs or other products that arenot controlled in the same way asMedicinal productsFinished products are often treated as newchemical entities with full proof ofquality, safety and efficacy being required.
  4. 4. 10- GMP &Qualitycontrol11- Post-marketingsurveillance12- Advertising,distribution& retail sale13-DifferencesbetweenMemberStatesEuropean Pharmacopoeia inall Member States 1964natural state after desiccation orconcentration or for the isolationof naturalactive ingredientsThe adverse reaction reportingSystems case of severalwithdrawals of marketing authorizationsfor herbal medicinal products due tosafety concern in connection withcertain plantsCouncil Directive 92/28/EEC on advertising innational lawWholesale marketing of all medicinalproducts aswell as authorized herbalmedicinal products is covered byCouncil Directive 92/25/EECdifferent traditions regarding thetherapeutic use ofmedicinal plant preparations,which maymake it more difficult for manufacturersof herbal medicinal products to apply formarketing authorization using thedecentralized procedure
  5. 5. Guidelines for the regulation ofherbal medicinesJapan
  6. 6. IntroductionJapanese traditional medicine, as used inJapanese society for 1000+++ years146 Kampo drugs are registered as drugsby the Ministry of Health and Welfare(MHW) and are included in coverageunder the National Health Insurance.Each Kampo drug is a formula usuallyconsisting of 5-10 different herbsLocal traditional usage is not sufficient forapproval as a drug; the claims and rules ofcombinations of herbal ingredients aredetermined on the basis of thepharmacological actions of theingredients.If a monograph is not available, the claimsreported in the Japanese Pharmacopoeiaare used as a guide.
  7. 7. IntroductionThe same data required for new ‘western’ drugs arerequired for new Kampo drugs, including data fromthree-phase clinical trials.1986 GMP Law, the standard applied to allpharmaceutical drugs has also applied to Kampodrugs.1985, guidelines for ethical extract products in orientalmedicine formulations were developedThe MHW has three major systems for collection ofadverse reaction data.1st- is a voluntary system involving 2915 monitoringhospitals.2nd- system — the Pharmacy Monitoring System —which includes 2733pharmacies, collects data oncases.3rd- system is Adverse Reaction Reporting fromManufacturers.
  8. 8. Regulatory situationRegulatory situationRegulatory situationRegulatory situationThey are regarded as a form of combined drug, and thesame data required for new Western drugs arerequired for new Kampo drugs in the NDA.The time-consuming and expensive chronic toxicitytests and special toxicity tests such as for(a)Mutagenicity,(b) carcinogenicity and(c) teratogenicityData for 3 phase clinical trials are also requiredFor generic Kampo drugs, bioequivalence data arerequired, which may discourage development,because pharmacokinetic studies of Kampo drugsare difficult to conduct and bioassay methods arequite limited.When using substances listed in Japanese Standardsfor Herbal Medicines as materials or ingredients ofpharmaceutical products to be manufactured/imported into, Japan -should comply
  9. 9. Regulatory situationRegulatory situationRegulatory situationRegulatory situationRegulations for Manufacturing Controland Quality Control of Drugs effect inApril 1996.The Japan Pharmacists Education Centre(243) issues a certificate for pharmacistsspecializing in kampo medicines andherbal materials in accordance with itsown qualification criteria.Renewal of this certification is requiredevery 3 years.This system requires all registeredspecialists to attend authorized meetingsof the Society and to present relevantscientific papers and medical journalsat the meetings.This registration system requiresregistration as a specialist in kampomedicine to be renewed every 5 years,