ElderGLOBAL REGULATORY     ASPECTS  By Poonam Bhardwaj      JANUARY 2012                         1
ElderWhere have the regulations come            from?3,500 years ago ancient Egyptians were strict    Rules of medicines w...
Elder REGULATORYRegulatory Affairs (RA)Regulatory Authority                            3
Elder REGULATORY AFFAIRSThe Pharmaceutical Biotechnology and     Pharmaceutical,Medical device, and Research &Development ...
REGULATORY TERRITORIES  North America (US , Canada)  Europe (Europe Union, Eastern Europe)  Japan  J  Rest Of the World i....
ElderREGULATORY TERRITORIESBusiness Boundaries are dissolving                        dissolving.The world pharmaceutical r...
ElderREGULATORY TERRITORIESBased on the “Economy” and              Economy“Regulatory Control” of the countries,these are ...
ElderREGULATORY TERRITORIESBased on the “Economy” and              Economy“Regulatory Control” of the countries,these are ...
ElderREGULATORY TERRITORIESRegulated Markets US EU Japan ANZ (Australia, NewZealand)                                 9
ElderREGULATORY TERRITORIES European Union Member StatesAustria          Greece          NetherlandsBelgium          Hunga...
ElderREGULATORY TERRITORIESEmerging Markets Asia Pacific ASEAN GCC (Gulf Co operation Council)             Co-operation LA...
Elder REGULATORY TERRITORIESREGION                      COUNTRIESAsia Pacific -- ASEAN       Indonesia, Malaysia, Philippi...
Elder 13
ElderREGULATORY AUTHORITY     Regulatory Agency      Regulatory Body     Regulatory Authority      Government Body       H...
Elder REGULATORY AUTHORITYCountry     Regulatory AuthorityArgentina    National Administration of Drugs, Food &           ...
Elder REGULATORY AUTHORITYCountry   Regulatory AuthorityDenmark    Danish Medicines AgencyEurope     European Directorate ...
Elder  REGULATORY AUTHORITYCountry       Regulatory AuthorityItaly          Italian Pharmaceutical AgencyJapan          Ph...
Elder REGULATORY AUTHORITYCountry        Regulatory AuthorityPhilippines     Philippine Council for Health Research and   ...
Elder REGULATORY AUTHORITYCountry       Regulatory AuthoritySwitzerland    Swiss Agency for Therapeutic ProductsUganda    ...
Elder     FDA Regulatory Pyramid    US                         Laws                               L    Congress           ...
CFR = Code of US Federal Regulations                                            Elder                                     ...
Elder           21 CFR Part ……CFR Title 21 (Food and Drugs)                          g )    1. General Enforcement Regulat...
Elder                ICHInternational Conference on Harmonisation                  ofTechnical Requirements for Registrati...
Elder         ICH  Bringing together theregulatory authorities and pharmaceutical industry     of ………….???                ...
Elder  ICHUSA   Europe  Japan                25
Elder       Q                   S                 E               M   "Quality"           "Safety"         "Efficacy"     ...
Elder         ICH - QualityICH section                     Description                                      pQ1           ...
Elder                      ICHICH section                    Description                                     pQ6          ...
ElderREGULATORY SUBMISSIONSNomenclature of Documents:  DMF / ASMF (Drug Substance; DS)             (D    S b t  Dossier (D...
ElderREGULATORY SUBMISSIONSDrug Master File (DMF) is a master   g             (    )document containing complete informati...
ElderREGULATORY SUBMISSIONSDrug Dossier is a document which consist ofcomplete information of Drug product(Formulation). V...
ElderOK I am Ready to File    – No What?      Now      Its      It CTD                        32
ElderREGULATORY SUBMISSIONS             WHAT IS CTD??? CTD (Common Technical Document) is an application FORMAT prescribed...
Elder 34
ElderREGULATORY SUBMISSIONS TYPES OF CTD SUBMISSION PAPER SUBMISSION ELCTRONIC SUBMISSION (eCTD)                          ...
ElderPAPER SUBMISSION                    36
ElderELECTRONIC SUBMISSION(e( CTD)                         37
ElderRole of Regulatory AffairsProfessionals“Regulatory Affairs Professional ”   is the crucial link between   pharmaceuti...
ElderREGULATORY  AFFAIRS              39
ElderRole of Regulatory Affairs      Professionals Regulatory Affairs Unit in a p     g       y                  pharmaceu...
ElderRole of Regulatory Affairs      Professionals In such a scenario a small delay in gaining market                     ...
ElderRole of Regulatory Affairs      Professionals They ensure appropriate licensing, marketing and    y         pp p     ...
ElderRole of Regulatory Affairs      Professionals                              43
ElderIMPORTANT LINKS                   44
ElderIMPORTANT LINKS                   45
Elder   IMPORTANT LINKShttp://www.fda.gov/default.htm                                  46
Elder      IMPORTANT LINKShttp://www.edqm.eu/site/Homepage-http://www.edqm.eu/site/Homepage-628.htmlhttp://www.ema.europa....
Elder      IMPORTANT LINKShttp://www.pmda.go.jp/english/index.htmlhttp://www pmda go jp/english/index html                ...
ElderIMPORTANT LINKS  http://www.cdsco.nic.in/http://www.drugscontrol.org/http://www drugscontrol org/ http://www.fda-mah....
ElderCONCLUSION              50
Elder 51
Elder 52
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  1. 1. ElderGLOBAL REGULATORY ASPECTS By Poonam Bhardwaj JANUARY 2012 1
  2. 2. ElderWhere have the regulations come from?3,500 years ago ancient Egyptians were strict Rules of medicines were to be followed Reflected Quality, Safety & Efficacy Vigorously enforced Vi l f d If followed & patient died – absolution If b k & patient di d – d h penalty! broken i died death l ! 2
  3. 3. Elder REGULATORYRegulatory Affairs (RA)Regulatory Authority 3
  4. 4. Elder REGULATORY AFFAIRSThe Pharmaceutical Biotechnology and Pharmaceutical,Medical device, and Research &Development industries are most highlyregulated industries in the country. As India is growing very rapidly in thepharmaceutical sector, there is agrowing need of “Regulatory Affairs” to Regulatory Affairscater the current needs of industries forthe global competition competition. 4
  5. 5. REGULATORY TERRITORIES North America (US , Canada) Europe (Europe Union, Eastern Europe) Japan J Rest Of the World i.e. ROW(Asia Pacific Region, ANZ, LATAM, CEE, GCC, CIS) , ) 5
  6. 6. ElderREGULATORY TERRITORIESBusiness Boundaries are dissolving dissolving.The world pharmaceutical regulationsare in continues process ofharmonization.harmonization“Regulatory” is the key to enter into themarket of any Country. 6
  7. 7. ElderREGULATORY TERRITORIESBased on the “Economy” and Economy“Regulatory Control” of the countries,these are grouped into:Regulated M k tR l t d MarketsSemi Regulated MarketsNon Regulated Markets 7
  8. 8. ElderREGULATORY TERRITORIESBased on the “Economy” and Economy“Regulatory Control” of the countries,these are grouped into:Regulated M k tR l t d MarketsSemi Regulated / Emerging MarketsNon Regulated Markets 8
  9. 9. ElderREGULATORY TERRITORIESRegulated Markets US EU Japan ANZ (Australia, NewZealand) 9
  10. 10. ElderREGULATORY TERRITORIES European Union Member StatesAustria Greece NetherlandsBelgium Hungary NorwayBulgaria Iceland PolandCyprusC Ireland I l d Portugal P t lCzech Republic Italy RomaniaDenmark Latvia SlovakiaFinland Liechtenstein SloveniaEstonia Lithuania SpainFrance Luxembourg SwedenGermany Malta United Kingdom 10
  11. 11. ElderREGULATORY TERRITORIESEmerging Markets Asia Pacific ASEAN GCC (Gulf Co operation Council) Co-operation LATAM (Latin America) CEE (Central East Europe) CIS (Commonwealth Independent States) Africa Af i 11
  12. 12. Elder REGULATORY TERRITORIESREGION COUNTRIESAsia Pacific -- ASEAN Indonesia, Malaysia, Philippines, Singapore , Thailand, Brunei, Myanmar, Cambodia, Laos, Vietnam.GCC Bahrain, Kuwait, Oman, Qatar, Saudi Arabia,(Gulf Co-operation Council) and UAE.LATAM (Latin America) Brazil, Mexico, Venezuela Argentina, Chile, Columbia, Ecuador Guatemala, Barbados, BoliviaCEE (Central East Europe) Belarus, Bulgaria, Czech Republic, Hungary, Poland, Romania, Sl P l d R i Slovakia. kiCIS (Commonwealth Armenia, Azerbaijan, Belarus, Kazakhstan,Independent States) Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine Uzbekistan, Turkmenistan Ukraine, Uzbekistan GeorgiaAfrica South Africa, Ghana, Ethiopia, Kenya, 12 Tanzania, Luanda, Zambia, Sudan ..
  13. 13. Elder 13
  14. 14. ElderREGULATORY AUTHORITY Regulatory Agency Regulatory Body Regulatory Authority Government Body Health A th it H lth Authority 14
  15. 15. Elder REGULATORY AUTHORITYCountry Regulatory AuthorityArgentina National Administration of Drugs, Food & Medical Technology (ANMAT)Brazil Agência Nacional deVigilância Sanitária (ANVISA) National Health Surveillance AgencyBulgariaB l i Bulgarian D B l i Drug Agency (BDA) ACanada Health CanadaChina State Food and Drug Administration (SFDA) 15
  16. 16. Elder REGULATORY AUTHORITYCountry Regulatory AuthorityDenmark Danish Medicines AgencyEurope European Directorate for the Quality of Medicines and Healthcare (EDQM) & M di i dH l h European Medicines Agency (EMA)Germany Federal Institute for Drugs and Medical Devices (BfArM)India Central Drug Standard Control Organization (CDSCO) Food and Drug Administration (FDA) 16Ireland Irish Medicines Board
  17. 17. Elder REGULATORY AUTHORITYCountry Regulatory AuthorityItaly Italian Pharmaceutical AgencyJapan Pharmaceuticals and Medical Devices Safety Authority (PMDA)Netherlands Medicines Evaluation BoardNew Medsafe - Medicines and Medical DevicesZealand Safety AuthorityPakistanP ki t Drug C t l Organisation, Ministry of Health D Control O i ti Mi i t f H lth 17
  18. 18. Elder REGULATORY AUTHORITYCountry Regulatory AuthorityPhilippines Philippine Council for Health Research and Development (PCHRD)Poland Ministry of Health & Social WelfareSingapore Health Sciences Authority (HSA)Sri LankaS iL k Ministry f Healthcare and Nutrition Mi i t of H lth d N t itiSouth Africa Medicines Control Council (MCC) 18
  19. 19. Elder REGULATORY AUTHORITYCountry Regulatory AuthoritySwitzerland Swiss Agency for Therapeutic ProductsUganda National Council for Science and Technology (UNCST)UK Medicines and Healthcare Products Regulatory Agency (MHRA)USA The Food and Drug Administration (FDA)Yemen Ministry of Public Health and Population 19
  20. 20. Elder FDA Regulatory Pyramid US Laws L Congress Food, Drug & Cosmetic Act Regulations cGMP GLP = GxP 21 CFR Part 11; GCP 21 CFR Part 210, 211, 820, etc. Guidances Part 211. Current Good Manufacturing Practice for g Finished Pharmaceuticals. Standards GAMP 4 Guide; ISO 9000, IEEE Standards; ASTM Standards; USPharmacopeia (USP); International Conference on Harmonization (ICH) Slide 20
  21. 21. CFR = Code of US Federal Regulations Elder Title 26 Internal RevenueTitle 1 General Provisions Title 27 Alcohol, Tobacco Products and FirearmsTitle 2 [Reserved] Title 28 Judicial AdministrationTitle 3 The President Title 29 LaborTitle 4 Accounts Title 30 Mineral ResourcesTitle 5 Administrative Personnel Title Ti l 31 Money and Finance: Treasury M d Fi TTitle 6 [Reserved] Title 32 National DefenseTitle 7 Agriculture Title 33 Navigation and Navigable WatersTitle 8 Aliens and Nationality Title 34 EducationTitle 9 Animals and Animal Products Title 35 Panama CanalTitleTitl 10 Energy E Title 36 Parks, Forests, and Public PropertyTitle 11 Federal Elections Title 37 Patents, Trademarks, and CopyrightsTitle 12 Banks and Banking Title 38 Pensions, Bonuses, and Veterans ReliefTitle 13 Business Credit and Assistance Title 39 Postal ServiceTitle 14 Aeronautics and Space p Title 40 Protection of EnvironmentTitle 15 Commerce and Foreign Trade Title 41 Public Contracts and PropertyTitle 16 Commercial Practices ManagementTitle 17 Commodity and Securities Exchanges Title 42 Public HealthTitle 18 Conservation of Power and Water Title 43 Public Lands: InteriorResourcesR Title 44 Emergency Management and AssistanceTitle 19 Customs Duties Title 45 Public WelfareTitle 20 Employees Benefits Title 46 ShippingTitle 21 Food and Drugs Title 47 TelecommunicationTitle 22 Foreign Relations Title 48 Federal Acquisition Regulations SystemTitle 23 Highways Title 49 Transportation Title 50 Wildlife and Fisheries Slide 21Title 24 Housing and Urban DevelopmentTitle 25 Indians
  22. 22. Elder 21 CFR Part ……CFR Title 21 (Food and Drugs) g ) 1. General Enforcement Regulations 2. General Administrative Rulings and Decisions 3. Product Jurisdiction : 11. Electronic Records and Electronic Signatures : 58. G d L b 58 Good Laboratory Practice (GLP) t P ti : 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. 211. Current Good Manufacturing Practice for Finished Pharmaceuticals. : 820. Quality System Regulation (QSR) Device GMP Slide 22
  23. 23. Elder ICHInternational Conference on Harmonisation ofTechnical Requirements for Registration of Pharmaceuticals 23
  24. 24. Elder ICH Bringing together theregulatory authorities and pharmaceutical industry of ………….??? 24
  25. 25. Elder ICHUSA Europe Japan 25
  26. 26. Elder Q S E M "Quality" "Safety" "Efficacy" "Multi- disciplinary disciplinary" Topics i.e. those Topics i.e. those Topics i.e. those Topics i.e. relating to relating to in relating to cross-cutting chemical and vitro and in vivo clinical studies Topics which pharmaceutical pre-clinical in human do not fit Quality studies subject (Dose uniquely into Assurance (Carcinogenicity Response one of the(Stability Testing, Testing Studies Good above Impurity Testing G t i it I it T ti Genotoxicity Clinical Cli i l categories t i etc) Testing etc.) Practices etc.) 26
  27. 27. Elder ICH - QualityICH section Description pQ1 Stability StudyQ2(R1) Validation of Analytical ProceduresQ3A(R2) Impurities in New Drug Substances p gQ3B(R2) Impurities in New Drug ProductsQ3C(R4) Impurities: Guideline for Residual SolventsQ4 PharmacopoeiasQ5 Quality of Biotechnological Products 27
  28. 28. Elder ICHICH section Description pQ6 SpecificationsQ7 Good Manufacturing Practice Guide for Active Pharmaceutical IngredientsQ8(R2) Pharmaceutical DevelopmentQ9 Quality Risk ManagementQ10 Pharmaceutical Quality SystemQ 11 Development and Manufacture of Drug Substances 28
  29. 29. ElderREGULATORY SUBMISSIONSNomenclature of Documents: DMF / ASMF (Drug Substance; DS) (D S b t Dossier (Drug Product; DP) 29
  30. 30. ElderREGULATORY SUBMISSIONSDrug Master File (DMF) is a master g ( )document containing complete informationon API.Drug Master File (DMF)Compilation for open and closed partIt is a submission of documents, coveringfactual and complete information onchemistry, stability, purity, i h i t t bilit it impurity profile, it filpackaging and cGMP status of any API. 30
  31. 31. ElderREGULATORY SUBMISSIONSDrug Dossier is a document which consist ofcomplete information of Drug product(Formulation). Viz: Information on API and Excipients Manufacturing process M f t i Quality documents Pre-clinical study P li i l t d Clinical Study 31
  32. 32. ElderOK I am Ready to File – No What? Now Its It CTD 32
  33. 33. ElderREGULATORY SUBMISSIONS WHAT IS CTD??? CTD (Common Technical Document) is an application FORMAT prescribed pp p organization of the information required to be submitted. A harmonized format for a regulatory dossier that is considered acceptable in US, Japan Europe and other regulatory also. l 33
  34. 34. Elder 34
  35. 35. ElderREGULATORY SUBMISSIONS TYPES OF CTD SUBMISSION PAPER SUBMISSION ELCTRONIC SUBMISSION (eCTD) 35
  36. 36. ElderPAPER SUBMISSION 36
  37. 37. ElderELECTRONIC SUBMISSION(e( CTD) 37
  38. 38. ElderRole of Regulatory AffairsProfessionals“Regulatory Affairs Professional ” is the crucial link between pharmaceutical company, its products and worldwide regulatory authorities viz. viz USFDA, EMEA, etc. 38
  39. 39. ElderREGULATORY AFFAIRS 39
  40. 40. ElderRole of Regulatory Affairs Professionals Regulatory Affairs Unit in a p g y pharmaceutical company p y is a vital unit that drives the R & D efforts of the company to the market successfully. A Regulatory Affairs department is a dynamic business unit which works with a focus to get products to the market with a commercially viable label in the least possible time and expenses. The world has become a global village and many companies are in a race to place many new products in the world markets to gain market share and increase earnings. 40
  41. 41. ElderRole of Regulatory Affairs Professionals In such a scenario a small delay in gaining market y g g access means huge loss in terms of market share and revenue generated. The key to success for pharmaceutical companies lies in obtaining timely marketing approval from regulators. regulators So to obtain timely marketing approval companies can either strengthen the regulatory department or outsource the same to regulatory affairs consulting firm. 41
  42. 42. ElderRole of Regulatory Affairs Professionals They ensure appropriate licensing, marketing and y pp p g, g legal compliance of pharmaceutical and medical products. They combine scientific knowledge, legal and business issues and co ordinate the approval and co-ordinate registration. 42
  43. 43. ElderRole of Regulatory Affairs Professionals 43
  44. 44. ElderIMPORTANT LINKS 44
  45. 45. ElderIMPORTANT LINKS 45
  46. 46. Elder IMPORTANT LINKShttp://www.fda.gov/default.htm 46
  47. 47. Elder IMPORTANT LINKShttp://www.edqm.eu/site/Homepage-http://www.edqm.eu/site/Homepage-628.htmlhttp://www.ema.europa.eu/ema/index.jsp?cu p p j p rl=pages/home/Home_Page.jsp&mid= rl=pages/home/Home_Page.jsp&mid= 47
  48. 48. Elder IMPORTANT LINKShttp://www.pmda.go.jp/english/index.htmlhttp://www pmda go jp/english/index html 48
  49. 49. ElderIMPORTANT LINKS http://www.cdsco.nic.in/http://www.drugscontrol.org/http://www drugscontrol org/ http://www.fda-mah.com/ 49
  50. 50. ElderCONCLUSION 50
  51. 51. Elder 51
  52. 52. Elder 52

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