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  • DRUG REGULATORY AFFAIRSThe Backbone of pharmaceutical industryPresented by: Iram Naila Feb 28, 2015

  • Drug Regulatory Affairs

  • Regulatory AffairsPharmaceutical IndustryDrug Regulatory AuthorityRegulatory Affairs ProfessionalsBridging the gap...Key Players involved..

  • ObjectivesCreate awareness, Role of Drug Regulatory Affairs department in the progress of pharmaceutical industryResponsibilities of Pharmaceutical Regulatory Affairs Professionals

  • Nature of Pharmaceutical IndustryPharmaceutical Regulatory AffairsGlobal Drug Regulatory BodiesDrug Regulatory Authority of Pakistan Drug Regulation in PakistanRegulatory procedures in PakistanPharma Regulatory ProfessionalsGlobal Pharma Regulatory Professional AssociationsScope

  • Pharmaceutical Industry-ATTRIBUTESFast Growing market Highly Regulated industryEver changing regulationsIncreased globalizationHigh competitivenessHighly dependent on science & technologyCostly R&D, Innovation, InventionStringent Quality standardsDevelopment of new therapeutic fields & technologies Quick development of the world generic markets Increased importance of strategic management Increased importance of regulatory issues (registrations, intellectual property)

  • The Pharmaceutical Industry has Mediated the Opposite ForcesPharmaceutical IndustryScientific InnovationEconomic Factors

  • The key to success lies in driving the Research and Development (R&D) efforts of the company to the market in the least possible time & expense with a commercially viable label

  • Identification & Compliance of Regulatory Requirements Strategic guidance & technical advice to R&D, Production, QC dept of the company Regulatory submissions and approvals Keep record of ever-changing legislationRole of RA

  • Any activity with DRUG..By whom? (the authority)Does not belong to drug regulatory affairsYesPrior authorisation/submission needed?Based on which criteria?(objective and subjective)Subject to regular control?(quality, inspection)By whom? (the authority)Based on which criteria?(objective and subjective))NO

  • Regulatory Affairs

  • Court Room Scenario..

  • Communication Gap Inadequate reporting of data hamper timely & positive evaluation of registration application. Even worse, release of product bearing incorrect labeling product recall. Loss of sales, image of the product, Brand equityFor example;

  • Regulatory Affairs

  • RegulationsOur life is regulated in many different ways continuously

  • *Ethical rulesProfessional rules (soft law)Hard lawCustom, fashion, common courtesyHierarchy of the Rules

  • Hierarchy of the most important professional rules

    Hard law

    Soft lawConstitutionActs of ParliamentGovernment laws Rules framed under Govt. laws

    Guidelinesmethodological letters of National Boards/InstitutesScientific literature+-HIERARCHI

  • Almost Everybody knows about Cricket game in Pakistan Imagine a very good cricketerHis only problem is that he does not know the rules e.g. No Ball, LBW, etc.your opinion. can he be successful as a team member?

  • The same is valid for Drug Regulatory Affairs! More than simply administration! The Art of Pharmacy belongs to the Regulated Field! Thus, to know the relevant regulations is the professional life itself! The problem is: we can not simply learn it, Instead, we must understand the logic behind it!

  • Drug Law in PakistanLaw maker: Parliament, Govt. of PakistanImplementation of Law: Drug Regulatory Authority of Pakistan (DRAP)Execution of Drug Laws: Pharmaceutical companiesPharmaciesRegulators

  • Drug Regulatory Authority of Pakistan (DRAP) Act 2012 Drugs Act 1976 The Drugs (Labeling and Packaging) Rules 1986 The Drugs (Licensing, Registration and Advertisement) Rules 1976 The Drugs (Appellate) Rules 1976 The Drugs (Research) Rules 1978 The Drugs (Federal Inspector, Federal Drug Laboratory & Federal Government Analyst) Rules 1976 The Drugs (Import & Export) Rules 1976 The Drugs (Specification) Rules 1978Drug Law in Pakistan

  • Extends to whole PakistanEstablishment of DRAPPolicy BoardChange in definition of drug.Some new definitions i.e. Therapeutic goods, Medical Device, Alternative medicine, Health & OTC Products.Control of Non pharma drugs Power of Federal Govt. to make rules Power of provincial Govt. to make rulesRefers to Drugs Act for regulatory procedures & approvalsDrugs Act 1976 is still there.DRAP ACT 2012

  • It extends to the whole of Pakistan Regulates drug Import, Export, Manufacture, Storage, Distribution and SaleRegistration of drugs under this Act would not constitute defense against infringement regulated by Patent and Design Act 1911.Application of other laws not barredDrugs Act 1976

  • Drugs Act 1976Composition: Preamble and ScopeDefinitionsAdministration and EnforcementProhibitionOffence, Penalties and ProcedurePower of Federal Govt. to make rulesPower of provincial Govt. to make rulesRepeal and Savings

  • Drug Regulatory Authority of Pakistan- DRAP Established under the DRAP Act 2012Concerned Ministry; National Health Services & Regional CoordinationAims & ObjectivesTo provide effective coordination and enforcement of Drugs Act, 1976 for provision of drugs and therapeutic goods that are safe, effective, quality and economical.To bring harmony in interprovincial trade and commerce of drugs and therapeutic goods

  • Drug Regulatory Authority of Pakistan- DRAP Policy Board of DRAP: Policies and guidelines implementation of the guidelines Functions of functions of DRAP approve budget of DRAP Determine all fees and levies

  • DRAP-ResponsibilitiesRegulatory Approvals Registration & Post Registration Variations of pharmaceutical drugs, Biologicals, Medical Devices, HealthProducts, Alternative Medicine.Licensing of Drug Manufacturing units, Biological Manufacturing facilities, Alternative Medicine manufacturing facilitiesPricing of products Quality Control functionPharmacovigilanceGuideline: cGMP Guidelines, Guidelines forEnlistment and Registration of Alternative Medicines, Guidelines for Licensing of Pharmaceutical Units.PoliciesContract Manufacturing PolicyImport PolicyPricing Policy

  • Pharmaceutical Licensing Receipt of proposalSite verification by inspectionApproval of Layout(Central Licensing Board/Committee_Formal application after site approvalPanel InspectionReport to CLB(Central Licensing Board)Deficiency:Approval suspendedReapplication after 3-6 monthsRejection of applicationApproval and grant of license

  • Marketing Authorization

  • USA : Food and Drug Administration (FDA) Europe: European Medicines Agency (EMA) Japan: Pharmaceuticals and Medical Devices Agency (PMDA) UK: Medicine and Healthcare Products Regulatory Agency (MHRA) Australia: Therapeutic Goods Administration (TGA)Historically, the various regulatory authorities have had their own regulatory procedures..Inconvenience & High CostInternational Conference on Harmonization (ICH) is an attempt to co-ordinate and synthesize international regulatory requirements.Global Drugs Regulatory Bodies

  • Members (Steering CommitteeUS Food and Drugs Administration (FDA)Pharmaceutical Research and Manufacturers of America (PhRMA)European Medicine Agency (EMA)European Federation of Pharmaceutical Industries Associations (EFPIA) Japan Ministry of Health, Labour, and Welfare (MHLW ) Japan Pharmaceutical Manufacturers Association JPMAInternational Federation of Pharmaceuticals Manufacturers (IFPMA)Observers: Health Canada WHOEuropean Fair Trade Association (EFTA)ICH

  • Q: "Quality" Topics, i.e., Chemical and pharmaceutical Quality Assurance (Stability Testing, Impurity Testing, etc.)S: "Safety" Topics, i.e., those relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing etc.)E: "Efficacy" Topics, i.e., those relating to clinical studies in human subject (Dose Response Studies, Good Clinical Practices, etc.)M: "Multidisciplinary" Topics, i.e., cross-cutting Topics which do not fit uniquely into one of the above categoriesICH Guidelines For details:

  • Regulatory professional is central to the business Relate to almost every discipline within the industry

  • Associations of Pharma RAUS: Regulatory Affairs Professional Society (RAPS)

    UK: The Organization of Pharmaceutical Regulatory Affairs

    Canada: Canadian Association of Professionals in Regulatory Affairs

  • The RA professionals-Roles and ResponsibilitiesRole starts from research and development phasesmoving into clinical trials extending through premarket approvalsmanufacturinglabeling and advertisingPost marketing Surveillance

  • The RA professionals-Roles and ResponsibilitiesResponsible forUse and assimilate information provided by all departmentspresent that information to regulatory authorities i.e. for registration, licensing and other approvalsfeed back their opinions to the rest of the company Subsequent negotiations to obtain and maintain Regulatory approvalsRegulatory IntelligenceStrategic and technical advice at the highest level .. an important contribution both commercially and scientifically to the success of a development programme Ensure Regulatory Compliance for companys products

  • Key Regulatory CompetenciesUnderstanding of Pharmaceutical sectorknowledge of regulations. Tracking of regulatory changes and interpretation the implications of the regulations to the organization. Knowledge and application of regulatory approval procedures: Good Manufacturing Practice (GMP) Knowledge and application of Pharmacovigilance Knowled