1. InEtUe rGnCaPti onal Conference onHarmonization (ICH)Consolidated GuidelinesPravin CumarHead Academics

2. EU GCPWhat is ICH?Need to harmoniesPurpose of harmonizationInitiation of ICHObjectives of ICHThe Structure of ICHThe process of HarmonizationICH Guidelines Q, S, E & MICH & the FutureThe Impact of ICH 3. EU GCPICH is a unique joint initiativeinvolving both regulators andindustry as equal partners in thescientific and technicaldiscussions of the testingprocedures which are required toensure and assess the safety,quality and efficacy of medicines. 4. EU GCPAwareness on critical evaluation ofmedicinal products before market releaseMedical tragedies1960-70s:Rapid increase in laws, regulations & guidelineson medicinal productsGlobalization of Pharmaceutical industryBut regulation of medicine remained as anational responsibility 5. EU GCPThese changes lead to:Duplication of workRaising cost of health careEscalation of R&D costsDelay in drug development 6. EU GCPThe purpose is to makerecommendations on ways to achievegreater harmonization in theinterpretationApplication of technical guidelinesRequirements for product registration inorder to reduce or obviate the need toduplicate the testing carried out duringthe research and development of newmedicines. 7. EU GCPAim to produce a single set of technicalrequirements for the registration of newdrug, drug products to streamlinedevelopment.Reduce or obviate duplicate testingMore economical use of human, animal andmaterial resources.Eliminate unnecessary delays in theavailability of new medicines. 8. EU GCPAvailability of new medicines whilstmaintaining safeguards on quality, safetyand efficacy, and regulatory obligations toprotect public health.To provide a unified standard for theEuropean Union (EU), Japan & UnitedStates to facilitate mutual acceptance ofclinical data by the regulatory authoritiesin these jurisdictions 9. EU GCPMember:Steering committee (SC):ICH Parties - 6ICH Coordinators (One from each party)Observers - 3 (non-voting)IFPMA: SecretariatExpert Working Groups (EWGs) 10. EU GCPExpert working group: The SC isadvised on technical issues concernedwith harmonization topics by ExpertWorking Groups.They are nominated from the 6 Co Sponsors. 11. EU GCP ParticipantsSix Parties: EU, EFPIA, FDA,MHLW, JPMA, PhRMA,Three Observers: WHO, EFTA, CanadaEuropean Commission - European Union (EU) European Federation of Pharmaceutical Industriesand Associations (EFPIA) US Food and Drug Administration (FDA) Pharmaceutical Research and Manufacturers ofAmerica (PhRMA) Ministry of Health, Labor and Welfare, Japan (MHLW) Japan Pharmaceutical Manufacturers Association(JPMA) 12. EU GCPSTEERING COMMITTEE: Oversees the preparation for ICH andthe harmonization initiatives undertaken under the ICH Process. 2 members from each of the 6 co-sponsors Determines policies & procedures Selects topics for harmonization Monitors progress of harmonizationinitiatives 13. EU GCP Five-step approach Step 1: Consensus building Step 2: Confirmation of six-party harmonisedand consensus text released Step 3: Regulatory Consultation andDiscussion outside the ICH Step 4: Adoption of an ICH HarmonizedGuideline Step 5: Implementation 14. EU GCPQuality (Q)- chemical & pharmaceutical QASafety (S)dealing with in vitro & in vivo pre clinicaltestingEfficacy (E)clinical studies in human beingsMultidisciplinary (M)TerminologyElectronic StandardsCommon Documents 15. EU GCPQ 1(A-F): Stability - PhotostabilityQ 2: Analytical ValidationQ 3(A-C): ImpuritiesQ 5(A-E): Biotechnological QualityQ 6(A,B): SpecificationsQ 7: GMP for active pharma ingredientsQ 8: Pharmaceutical developmentQ 9: Quality risk managementQ10: Pharmaceutical Quality System 16. EU GCPS1: Carcinogenicity studies Need,Testing, Dose SelectionS2: Genotoxicity Regulatory, Battery of TestsS3A: ToxicokineticsS3B: PharmacokineticsS4: Chronic Toxicity TestingS5A: Toxicity to ReproductionS5B: Toxicity to Male FertilityS6: Preclinical Biotech derived drugsS7A: Safety PharmacologyS7B: QT interval prolongationS8: Immunotoxicity for Human PharmaceuticalsS9 : Nonclinical Evaluation for Anticancer Pharmaceuticals 17. EU GCPE 1: Exposure to assess clinical safetyE 2: Clinical Safety Data ManagementE 3: Study ReportsE 4: Dose Response StudiesE 5: Ethnic FactorsE 6: Good Clinical Practice (GCP)E 7: Special Populations GeriatricsE 8: Clinical Trials DesignE 9: Statistical Considerations 18. EU GCPE 10: Choice of Control GroupE 11: Special Populations ChildrenE 12: Therapeutic categoriesE 14: The clinical evaluation of QT/QC interval prolongation &pro arrhythmic potential for non antiarrhythmic drugsE15: Definitions for Genomic Biomarkers,Pharmacogenomics, Pharmacogenetics, Genomic Data& Sample Coding CategoriesE16: Genomic Biomarkers Related to Drug Response:Context, Structure and Format of QualificationSubmissions 19. EU GCPM1: Medical TerminologyM2: Electronic Standards for Transfer ofRegulatory Information & Data (ESTRI)M3: Maintenance of ICH guidelines for nonclinicalsafety studiesM4: Common Technical Document (CTD)M5: Data Elements and Standards for DrugDictionaries 20. EU GCPIMPACT :Enhanced patient safetyStreamline development programsCommon quality standardReduce resource requirementsForum for CommunicationOpportunity for Industry & Regulators to sit acrossthe tableDiscuss drug development procedure with acommon goal of identifying best scientificpractice and applying the same uniformly acrossthe globe 21. FDA & CFR 22. US FOOD & DRUG ADMINISTRATION The Food and Drug Administration is one ofthe nation's oldest and most respectedconsumer protection agencies.www.fda.gov 23. FDA's mission FDA's mission is: To promote and protect the public health byhelping safe and effective products reach themarket in a timely way, To monitor products for continued safety afterthey are in use, and To help the public get the accurate, science-basedinformation needed to improve health. 24. Overview At the heart of all FDA's regulatory activities is ajudgment about whether a new product's benefits tousers will outweigh its risks. Science-based, efficient risk management allows theagency to provide the most health promotion andprotection at the least cost to the public. No regulated product is totally risk-free, so thesejudgments are important. FDA will allow a productto present more of a risk when its potential benefit isgreat -- especially for products used to treat serious,life-threatening conditions. 25. FDA DepartmentsFDA is an agency within the Department ofHealth and Human Services and consists of 9centers/offices. Center for Biologics Evaluation and Research(CBER) Center for Devices and Radiological Health(CDRH) Center for Drug Evaluation and Research(CDER) 26. Contd Center for Food Safety and Applied Nutrition(CFSAN) Center for Veterinary Medicine (CVM) National Center for Toxicological Research(NCTR) Office of Chief Counsel Office of the Commissioner (OC) Office of Regulatory Affairs (ORA) 27. CBER CBER's mission is to protect and enhance the publichealth through the regulation of biological and relatedproducts including blood, vaccines, allergenics, tissues,and cellular and gene therapies. Biologics, in contrast to drugs that are chemicallysynthesized, are derived from living sources (such ashumans, animals, and microorganisms), are not easilyidentified or characterized, and many are manufacturedusing biotechnology. 28. CBER These products often represent cutting-edgebiomedical research and, in time, may offer themost effective means to treat a variety ofmedical illnesses and conditions that presentlyhave few or no other treatment options. 29. CDRH More than 20,000 firms worldwide produce over80,000 brands and models of medical devices forthe U.S. market, ranging from contact lenses andblood sugar monitors to implanted hip joints andheart valves. The FDA's Center for Devices and RadiologicalHealth (CDRH) makes sure that new medicaldevices are safe and effective before they aremarketed. 30. Contd Many of these devices are the first of a kind,such as a robotic arm that can operate a varietyof surgical tools with tremendous precision. Other high-tech devices are designed toprevent, diagnose or treat cancer, heart disease,impaired vision and hearing, and other healthproblems. 31. Contd. The center also monitors devices throughoutthe product life cycle, including a nationwidepostmarket surveillance system. And it assures that radiation-emitting products,such as microwave ovens, TV sets, cell phones,and laser products meet radiation safetystandards. 32. CDER The FDA's Center for Drug Evaluation andResearch (CDER) promotes and protects thehealth of Americans by assuring that allprescription and over-the-counter drugs aresafe and effective. CDER evaluates all new drugs before they aresold, and serves as a consumer watchdog forthe more than 10,000 drugs on the market to besure they continue to meet the higheststandards. 33. Contd The center routinely monitors TV, radio, andprint drug ads to ensure they are truthful andbalanced. CDER also plays a critical role in providinghealth professionals and consumersinformation to use drugs appropriately andsafely. 34. CDER regulates- Prescription Drugs: Prescription medicinesinclude any drug product that requires adoctor's authorization to purchase. Generic Drugs: A generic drug is a drugproduct that is equivalent to brand nameproducts in terms of quality and performance. Over-the-Counter Drugs: OTC drug productsare available to consumers without a doctor'sprescription. 35. Title 21CFR 36. Introduction Title 21 is the portion of the Code of FederalRegulations that governs food and drugs withinthe United States for the Food and DrugAdministration (FDA), the Drug EnforcementAdministration (DEA), and the Office ofNational Drug Control Policy (ONDCP). 37. It is divided into three chapters: Chapter I Food and Drug Administration Chapter II Drug EnforcementAdministration Chapter III Office of National Drug ControlPolicy 38. Chapter I Most of the Chapter I regulations are based on theFederal Food, Drug, and Cosmetic Act. Notable sections: 11 - electronic records and electronic signaturerelated 50- Protection of human subjects in clinical trials 56- Institutional Review Boards that oversee clinicaltrials 58- Good Laboratory Practices (GLP) for nonclinicalstudies 39. The 100 series are regulations pertaining to food: 101, especially 101.9 Nutrition facts label related 106-107 requirements for infant formula 110 cGMPs for food products 170 food additives 190 dietary supplements 40. The 200 and 300 series are regulationspertaining to pharmaceuticals : 202-203 Drug advertising and marketing 210 cGMPs for pharmaceuticals 310 Requirements for new drugs 328 Specific requirements for over-the-counter(OTC) drugs. 41. The 500 series are regulations for animal feedsand animal medications: The 600 series covers biological products (e.g.vaccines, blood): The 700 series includes the limited regulationson cosmetics: The 800 series are for medical devices: 42. The 900 series covers mammography qualityrequirements enforced by CDRH. The 1000 series covers radiation emittingdevice (e.g. lasers, cell phones) requirementsenforced by CDRH. The 1200 series consists of rules primarilybased in laws other than the Food, Drug, andCosmetic Act: 43. Chapter II 1308.11 List of Schedule I drugs 1308.12 List of Schedule II drugs 1308.13 List of Schedule III drugs 1308.14 List of Schedule IV drugs 1308.15 List of Schedule V drugs 44. Chapter III 1405 Government wide requirements for drug-freeworkplaces 45. EU GCPTHANK YOU