Global emerging markets, Introduction to mapping countries and study of regional harmonization committees

Global emerging markets, Introduction to mapping countries and study of regional harmonization committees

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  UNIT - 4 GLOBALEMERGING MARKETS & HARMONIZATION INTRODUCTION TO EMERGING MARKETS, MAPPING COUNTRIES, AND STUDY OF REGIONAL HARMONIZATION COMMITTEES (ASEAN, APEC, EAC, GCC, PANDRH, SADC). Presented by: Chintakunta Poojitha M. Pharm Regulatory Affairs – 2nd sem 1704-25-867-005 Subject : Regulatory Aspects Of Drugs & Cosmetics SAROJINI NAIDU VANITA PHARMACY MAHA VIDYALAYA (CO – ED) (Sponsored By The Exhibition Society) (UGC AUTONOMOUS INSTITUTION) Affiliated To Osmania University Approved By PCI, NBAAccredited, Accredited A+ Grade By NAAC
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  CONTENTS • Introduction toEmerging Markets • Characteristics & Importance of Emerging Markets • Mapping of Global Emerging Markets • Concept of Regulatory Harmonization • Regional Harmonization Initiatives – ASEAN, APEC, EAC, GCC, PANDRH & SADC • Conclusion • References
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  INTRODUCTION TO EMERGINGMARKETS • Emerging markets are economies undergoing rapid economic and industrial development. They are generally moving toward more developed and mature economic systems. • They have growing:  Healthcare infrastructure  Pharmaceutical industries  Manufacturing capabilities  Middle-class populations  Foreign investment • Examples: India, China, Brazil, Indonesia, Vietnam, South Africa & Saudi Arabia
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  • Rapid economicgrowth • Growing healthcare and pharmaceutical sector • Evolving regulatory systems • Different requirements between countries • Higher cost and delays in product approval • Need for regulatory harmonization CHARACTERISTICS & REGULATORY CHALLENGES
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  MAPPING GLOBAL EMERGINGMARKETS • Major Emerging-Market Regions Region Examples of Countries Asia India, Indonesia, Malaysia, Thailand, Vietnam Africa Kenya, Uganda, Tanzania, South Africa, Zambia Middle East Saudi Arabia, UAE, Qatar, Oman, Kuwait Latin America Brazil, Mexico, Argentina, Chile, Colombia
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  WHAT IS REGULATORYHARMONIZATION? • Regulatory harmonization is the process of developing similar or compatible regulatory requirements among different countries. • Main objectives:  Reduce duplication  Establish common technical requirements  Improve regulatory efficiency  Facilitate medicine registration  Reduce development and registration costs  Improve patient access to medicines • Simple concept: Different requirements → Harmonization → Common/convergent requirements → Easier market access
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  MAJOR REGIONAL HARMONIZATION INITIATIVES •The major initiatives covered in this topic are:
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  ASEAN • ASEAN –Association of Southeast Asian Nations • Region: Southeast Asia • Pharmaceutical harmonization includes: • ASEAN Common Technical Dossier (ACTD) • ASEAN Common Technical Requirements (ACTR) • Cooperation among national regulatory authorities • Common approaches to quality, safety and efficacy • Benefits: • Reduces duplication • Facilitates pharmaceutical registration • Supports regional pharmaceutical trade
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  APEC • APEC –Asia-Pacific Economic Cooperation • Region: Asia-Pacific • APEC supports regulatory cooperation and convergence in the pharmaceutical and healthcare sectors. • Major areas:  Good Regulatory Practices  Regulatory convergence  Capacity building  Medical products regulation  Information sharing • Importance: Helps regulatory authorities develop efficient and internationally compatible regulatory systems.
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  EAC • EAC –East African Community • Region: East Africa • Pharmaceutical harmonization focuses on: • Medicines registration • Common technical requirements • GMP • Quality standards • Regulatory capacity building • Benefits: • Reduces repeated regulatory assessments • Strengthens regulatory authorities • Improves access to medicines • Promotes cooperation between member countries
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  GCC • GCC –Gulf Cooperation Council • Region: Gulf countries • Member countries: • Bahrain • Kuwait • Oman • Qatar • Saudi Arabia • United Arab Emirates • Regulatory cooperation includes:  Drug registration  Quality requirements  Regulatory procedures  Information and expertise sharing • Goal: Improve consistency and efficiency of pharmaceutical regulation across the Gulf region.
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  PANDRH PANDRH – PanAmerican Network for Drug Regulatory Harmonization • Region: Americas • PANDRH promotes cooperation and regulatory convergence among countries in the Americas. • Main areas:  Medicines regulation  Regulatory capacity building  Quality, safety and efficacy  Information sharing  Strengthening national regulatory authorities • Importance: Supports development of stronger and more consistent regulatory systems.
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  SADC • SADC –Southern African Development Community • Region: Southern Africa • Pharmaceutical harmonization focuses on:  Medicines registration  GMP  Quality assurance  Regulatory capacity building  Information sharing  Harmonized regulatory procedures • Goal: Improve availability of quality-assured medicines and strengthen regional regulatory systems.
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  COMPARISON & BENEFITS InitiativeRegion Major Focus ASEAN Southeast Asia ACTD & ACTR APEC Asia-Pacific Regulatory convergence EAC East Africa Medicines registration GCC Gulf Drug registration PANDRH Americas Regulatory cooperation SADC Southern Africa Medicines harmonization Overall benefits: Reduced regulatory duplication Lower costs Better use of regulatory resources Faster and more efficient registration Improved regulatory capacity Better access to quality medicines
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  CONCLUSION • Emerging marketsare becoming increasingly important to the global pharmaceutical industry. • Regulatory differences can create barriers to market access. • Regional harmonization helps countries develop compatible regulatory approaches. • ASEAN, APEC, EAC, GCC, PANDRH and SADC are important examples. • Harmonization supports regulatory convergence, efficient registration and improved access to medicines.
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  REFERENCES • ASEAN Secretariat.ASEAN Common Technical Dossier (ACTD). • APEC. Regulatory Harmonization Steering Committee (RHSC). • U.S. FDA. Asia-Pacific Economic Cooperation (APEC). • EAC. Medicines Regulatory Harmonization Programme. • GCC. GCC Health Council – Drug Registration. • PAHO/WHO. Pan American Network for Drug Regulatory Harmonization (PANDRH). • SADC. SADC Medicines Regulatory Harmonization. • WHO. WHO Guidelines for Medicines Regulation. • ICH. International Council for Harmonisation – Guidelines.