Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia

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dc.creatorTeo, Hui Sin
dc.creatorFoerg-Wimmer, Christina
dc.creatorChew, Pei-Lyn Melissa
dc.date2017-05-31T19:12:00Z
dc.date2017-05-31T19:12:00Z
dc.date2016
dc.date.accessioned2026-07-01T00:42:23Z
dc.descriptionEnsuring access to essential medicines is a key objective of all health systems, and is an integral component of the progress towards universal health coverage (UHC). Despite global and national efforts to improve access and affordability of medicines, millions of people – particularly in low- and middle-income countries – still remain without access to quality-assured and affordable medicines. This study aims to contribute to existing knowledge on regulatory systems and harmonization efforts in Southeast Asia. Focusing on five member states of the Association of Southeast Asian Nations (ASEAN) – Indonesia, Malaysia, the Philippines, Thailand, an Vietnam – this study gives an overview of pharmaceutical markets and key pharmaceutical policies in the region, provides a cross-country comparison of medicines regulatory systems, and details harmonization efforts, opportunities, and challenges.
dc.formatapplication/pdf
dc.identifierhttp://documents.worldbank.org/curated/en/727671496171008743/Medicines-regulatory-systems-and-scope-for-regulatory-harmonization-in-Southeast-Asia
dc.identifierhttps://hdl.handle.net/10986/26801
dc.identifier10.1596/26801
dc.identifier.urihttp://hdl.handle.net/123456789/409553
dc.languageEnglish
dc.languageen_US
dc.publisherWorld Bank, Washington, DC
dc.rightsCC BY 3.0 IGO
dc.rightshttp://creativecommons.org/licenses/by/3.0/igo
dc.rightsWorld Bank
dc.subjectTAX INCENTIVES
dc.subjectHARMONIZATION
dc.subjectREGULATORY FRAMEWORK
dc.subjectEXPORT MARKETS
dc.subjectSUPERVISION
dc.subjectEQUIPMENT
dc.subjectELECTRONIC DOCUMENT
dc.subjectKNOWLEDGE SHARING
dc.subjectCERTIFICATE
dc.subjectVITAMINS
dc.subjectMATERIALS
dc.subjectLAWS
dc.subjectTECHNICAL DOCUMENT
dc.subjectMORBIDITY
dc.subjectCAPABILITY
dc.subjectVALUE CHAIN
dc.subjectFINANCIAL RESOURCES
dc.subjectINFORMATION
dc.subjectMONITORING
dc.subjectHEALTH CARE
dc.subjectMARKET SHARES
dc.subjectINFORMATION SHARING
dc.subjectINTELLECTUAL PROPERTY RIGHTS
dc.subjectHEALTH
dc.subjectCAPACITY BUILDING
dc.subjectHOLISTIC APPROACH
dc.subjectPRICE
dc.subjectVERIFICATION
dc.subjectREGULATORY SYSTEMS
dc.subjectPRODUCT INFORMATION
dc.subjectFLOW OF GOODS
dc.subjectMANAGEMENT SYSTEMS
dc.subjectLEGAL BASIS
dc.subjectMARKET ACCESS
dc.subjectINFORMATION SYSTEMS
dc.subjectPRODUCT DEVELOPMENT
dc.subjectREGIONAL NETWORKS
dc.subjectPUBLIC HEALTH
dc.subjectLIFE EXPECTANCY
dc.subjectCOMPUTER
dc.subjectRADIATION
dc.subjectKNOWLEDGE
dc.subjectNEW TECHNOLOGIES
dc.subjectCOMMUNICATIONS
dc.subjectLEGAL FRAMEWORKS
dc.subjectINSTITUTIONS
dc.subjectHUMAN RESOURCE
dc.subjectDATA
dc.subjectANALGESICS
dc.subjectADVERTISING
dc.subjectTECHNICAL ASSISTANCE
dc.subjectCOMMERCE
dc.subjectLEGISLATIVE FRAMEWORK
dc.subjectPATIENTS
dc.subjectPATIENT
dc.subjectTECHNICAL DOCUMENTS
dc.subjectECONOMIC COOPERATION
dc.subjectTECHNICAL COOPERATION
dc.subjectLICENSE
dc.subjectTARGETS
dc.subjectBUSINESS NEEDS
dc.subjectAGING
dc.subjectGLOBALIZATION
dc.subjectREGULATORY SYSTEM
dc.subjectHEALTH MANAGEMENT
dc.subjectMARKETING
dc.subjectDRUG CONSUMPTION
dc.subjectCONSULTANT
dc.subjectSTANDARDIZATION
dc.subjectMATERIAL
dc.subjectSCREENING
dc.subjectINTERVIEW
dc.subjectDATABASES
dc.subjectMOVEMENT OF GOODS
dc.subjectMORTALITY
dc.subjectLEGAL FRAMEWORK
dc.subjectCAPABILITIES
dc.subjectTECHNICAL RESOURCES
dc.subjectACCESS TO INFORMATION
dc.subjectMANUFACTURING
dc.subjectTECHNOLOGY
dc.subjectINTERNATIONAL STANDARDS
dc.subjectR&D
dc.subjectTECHNICAL INFRASTRUCTURE
dc.subjectPDF
dc.subjectTECHNICAL RESOURCE
dc.subjectSYSTEM DEVELOPMENT
dc.subjectRELIABILITY
dc.subjectTRAINING COURSES
dc.subjectPROCUREMENT
dc.subjectINSPECTION
dc.subjectQUALITY MANAGEMENT
dc.subjectGLOBAL MARKET
dc.subjectBUSINESS PLAN
dc.subjectINTERNATIONAL TRADE
dc.subjectBEST PRACTICES
dc.subjectRESULTS
dc.subjectSURVEILLANCE
dc.subjectMARKET PRICES
dc.subjectTECHNICAL MEASURES
dc.subjectREGULATORY REQUIREMENTS
dc.subjectHEALTH POLICY
dc.subjectCAPACITY-BUILDING
dc.subjectMEDICAL DEVICES
dc.subjectHEALTH OUTCOMES
dc.subjectNETWORKS
dc.subjectTECHNICAL EXPERTISE
dc.subjectHYGIENE
dc.subjectMANAGEMENT SYSTEM
dc.subjectREGISTRATION APPLICATION
dc.subjectPROTOCOLS
dc.subjectDECISION MAKING
dc.subjectPRIVATE SECTOR
dc.subjectINSTITUTIONAL CAPACITY
dc.subjectDOCUMENT MANAGEMENT
dc.subjectWORKSHOPS
dc.subjectSUPPLY CHAIN
dc.subjectQUALITY CONTROL
dc.subjectQUALITY OF LIFE
dc.subjectMARKET SEGMENTS
dc.subjectADMINISTRATION
dc.subjectINVENTION
dc.subjectRESULT
dc.subjectELECTRONIC SUBMISSION
dc.subjectCAPACITY BUILDING TRAINING
dc.subjectGOVERNMENT POLICIES
dc.subjectREGISTRATION APPLICATIONS
dc.subjectE- COMMERCE
dc.subjectCOMMUNICABLE DISEASES
dc.subjectCARDIOVASCULAR DISEASES
dc.subjectSUPPLY CHAINS
dc.subjectMARKET SHARE
dc.subjectNETWORK
dc.subjectBUSINESS
dc.subjectBANDWIDTH
dc.subjectBIOTECHNOLOGY
dc.subjectHUMAN RESOURCES
dc.subjectISOLATION
dc.subjectPERFORMANCE
dc.subjectINSPECTIONS
dc.subjectRETENTION
dc.subjectCOMPETITIVE PRICES
dc.subjectBUSINESS PLANS
dc.subjectINNOVATION
dc.subjectCERTIFICATES
dc.subjectINSTITUTION
dc.subjectSITES
dc.subjectPROFIT
dc.subjectFUNCTIONALITY
dc.subjectTECHNICAL REQUIREMENT
dc.subjectWORLD TRADE
dc.subjectTECHNICAL SUPPORT
dc.subjectINTELLECTUAL PROPERTY
dc.subjectDECISION MAKING PROCESS
dc.subjectCOMMUNICATION
dc.subjectSUPPLY CHAIN MANAGEMENT
dc.subjectNEW TECHNOLOGY
dc.subjectSTRATEGY
dc.subjectRELIABLE ACCESS
dc.subjectCOMMODITIES
dc.subjectINSTITUTIONAL FRAMEWORK
dc.subjectREGISTRATION
dc.subjectMEDICINES
dc.subjectCOMMUNICATION STRATEGY
dc.subjectINSTITUTIONAL CAPACITIES
dc.subjectDATABASE
dc.subjectCOUNTRY OF ORIGIN
dc.subjectIP
dc.subjectTIMELY ACCESS
dc.subjectTECHNOLOGIES
dc.subjectTECHNICAL REQUIREMENTS
dc.subjectFINANCIAL CONSTRAINTS
dc.subjectHEALTH SERVICES
dc.subjectIMPLEMENTATION
dc.subjectTARGET
dc.subjectPRICES
dc.subjectUSES
dc.subjectUSER
dc.subjectTECHNICAL STANDARDS
dc.titleMedicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia
dc.typeReport
dc.typeRapport
dc.typeInforme

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