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Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia

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collection.link.95
https://openknowledge.worldbank.org/handle/10986/2203
collection.name.95
Other Health Study
dc.contributor.author
Teo, Hui Sin
dc.contributor.author
Foerg-Wimmer, Christina
dc.contributor.author
Chew, Pei-Lyn Melissa
dc.date.accessioned
2017-05-31T19:12:00Z
dc.date.available
2017-05-31T19:12:00Z
dc.date.issued
2016
dc.date.lastModified
2021-05-25T09:00:29Z
dc.description.abstract
Ensuring 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.
en
dc.identifier
http://documents.worldbank.org/curated/en/727671496171008743/Medicines-regulatory-systems-and-scope-for-regulatory-harmonization-in-Southeast-Asia
dc.identifier.uri
http://hdl.handle.net/10986/26801
dc.language
English
dc.language.iso
en_US
dc.publisher
World Bank, Washington, DC
dc.rights
CC BY 3.0 IGO
dc.rights.holder
World Bank
dc.rights.uri
http://creativecommons.org/licenses/by/3.0/igo
dc.subject
TAX INCENTIVES
dc.subject
HARMONIZATION
dc.subject
REGULATORY FRAMEWORK
dc.subject
EXPORT MARKETS
dc.subject
SUPERVISION
dc.subject
EQUIPMENT
dc.subject
ELECTRONIC DOCUMENT
dc.subject
KNOWLEDGE SHARING
dc.subject
CERTIFICATE
dc.subject
VITAMINS
dc.subject
MATERIALS
dc.subject
LAWS
dc.subject
TECHNICAL DOCUMENT
dc.subject
MORBIDITY
dc.subject
CAPABILITY
dc.subject
VALUE CHAIN
dc.subject
FINANCIAL RESOURCES
dc.subject
INFORMATION
dc.subject
MONITORING
dc.subject
HEALTH CARE
dc.subject
MARKET SHARES
dc.subject
INFORMATION SHARING
dc.subject
INTELLECTUAL PROPERTY RIGHTS
dc.subject
HEALTH
dc.subject
CAPACITY BUILDING
dc.subject
HOLISTIC APPROACH
dc.subject
PRICE
dc.subject
VERIFICATION
dc.subject
REGULATORY SYSTEMS
dc.subject
PRODUCT INFORMATION
dc.subject
FLOW OF GOODS
dc.subject
MANAGEMENT SYSTEMS
dc.subject
LEGAL BASIS
dc.subject
MARKET ACCESS
dc.subject
INFORMATION SYSTEMS
dc.subject
PRODUCT DEVELOPMENT
dc.subject
REGIONAL NETWORKS
dc.subject
PUBLIC HEALTH
dc.subject
LIFE EXPECTANCY
dc.subject
COMPUTER
dc.subject
RADIATION
dc.subject
KNOWLEDGE
dc.subject
NEW TECHNOLOGIES
dc.subject
COMMUNICATIONS
dc.subject
LEGAL FRAMEWORKS
dc.subject
INSTITUTIONS
dc.subject
HUMAN RESOURCE
dc.subject
DATA
dc.subject
ANALGESICS
dc.subject
ADVERTISING
dc.subject
TECHNICAL ASSISTANCE
dc.subject
COMMERCE
dc.subject
LEGISLATIVE FRAMEWORK
dc.subject
PATIENTS
dc.subject
PATIENT
dc.subject
TECHNICAL DOCUMENTS
dc.subject
ECONOMIC COOPERATION
dc.subject
TECHNICAL COOPERATION
dc.subject
LICENSE
dc.subject
TARGETS
dc.subject
BUSINESS NEEDS
dc.subject
AGING
dc.subject
GLOBALIZATION
dc.subject
REGULATORY SYSTEM
dc.subject
HEALTH MANAGEMENT
dc.subject
MARKETING
dc.subject
DRUG CONSUMPTION
dc.subject
CONSULTANT
dc.subject
STANDARDIZATION
dc.subject
MATERIAL
dc.subject
SCREENING
dc.subject
INTERVIEW
dc.subject
DATABASES
dc.subject
MOVEMENT OF GOODS
dc.subject
MORTALITY
dc.subject
LEGAL FRAMEWORK
dc.subject
CAPABILITIES
dc.subject
TECHNICAL RESOURCES
dc.subject
ACCESS TO INFORMATION
dc.subject
MANUFACTURING
dc.subject
TECHNOLOGY
dc.subject
INTERNATIONAL STANDARDS
dc.subject
R&D
dc.subject
TECHNICAL INFRASTRUCTURE
dc.subject
PDF
dc.subject
TECHNICAL RESOURCE
dc.subject
SYSTEM DEVELOPMENT
dc.subject
RELIABILITY
dc.subject
TRAINING COURSES
dc.subject
PROCUREMENT
dc.subject
INSPECTION
dc.subject
QUALITY MANAGEMENT
dc.subject
GLOBAL MARKET
dc.subject
BUSINESS PLAN
dc.subject
INTERNATIONAL TRADE
dc.subject
BEST PRACTICES
dc.subject
RESULTS
dc.subject
SURVEILLANCE
dc.subject
MARKET PRICES
dc.subject
TECHNICAL MEASURES
dc.subject
REGULATORY REQUIREMENTS
dc.subject
HEALTH POLICY
dc.subject
CAPACITY-BUILDING
dc.subject
MEDICAL DEVICES
dc.subject
HEALTH OUTCOMES
dc.subject
NETWORKS
dc.subject
TECHNICAL EXPERTISE
dc.subject
HYGIENE
dc.subject
MANAGEMENT SYSTEM
dc.subject
REGISTRATION APPLICATION
dc.subject
PROTOCOLS
dc.subject
DECISION MAKING
dc.subject
PRIVATE SECTOR
dc.subject
INSTITUTIONAL CAPACITY
dc.subject
DOCUMENT MANAGEMENT
dc.subject
WORKSHOPS
dc.subject
SUPPLY CHAIN
dc.subject
QUALITY CONTROL
dc.subject
QUALITY OF LIFE
dc.subject
MARKET SEGMENTS
dc.subject
ADMINISTRATION
dc.subject
INVENTION
dc.subject
RESULT
dc.subject
ELECTRONIC SUBMISSION
dc.subject
CAPACITY BUILDING TRAINING
dc.subject
GOVERNMENT POLICIES
dc.subject
REGISTRATION APPLICATIONS
dc.subject
E- COMMERCE
dc.subject
COMMUNICABLE DISEASES
dc.subject
CARDIOVASCULAR DISEASES
dc.subject
SUPPLY CHAINS
dc.subject
MARKET SHARE
dc.subject
NETWORK
dc.subject
BUSINESS
dc.subject
BANDWIDTH
dc.subject
BIOTECHNOLOGY
dc.subject
HUMAN RESOURCES
dc.subject
ISOLATION
dc.subject
PERFORMANCE
dc.subject
INSPECTIONS
dc.subject
RETENTION
dc.subject
COMPETITIVE PRICES
dc.subject
BUSINESS PLANS
dc.subject
INNOVATION
dc.subject
CERTIFICATES
dc.subject
INSTITUTION
dc.subject
SITES
dc.subject
PROFIT
dc.subject
FUNCTIONALITY
dc.subject
TECHNICAL REQUIREMENT
dc.subject
WORLD TRADE
dc.subject
TECHNICAL SUPPORT
dc.subject
INTELLECTUAL PROPERTY
dc.subject
DECISION MAKING PROCESS
dc.subject
COMMUNICATION
dc.subject
SUPPLY CHAIN MANAGEMENT
dc.subject
NEW TECHNOLOGY
dc.subject
STRATEGY
dc.subject
RELIABLE ACCESS
dc.subject
COMMODITIES
dc.subject
INSTITUTIONAL FRAMEWORK
dc.subject
REGISTRATION
dc.subject
MEDICINES
dc.subject
COMMUNICATION STRATEGY
dc.subject
INSTITUTIONAL CAPACITIES
dc.subject
DATABASE
dc.subject
COUNTRY OF ORIGIN
dc.subject
IP
dc.subject
TIMELY ACCESS
dc.subject
TECHNOLOGIES
dc.subject
TECHNICAL REQUIREMENTS
dc.subject
FINANCIAL CONSTRAINTS
dc.subject
HEALTH SERVICES
dc.subject
IMPLEMENTATION
dc.subject
TARGET
dc.subject
PRICES
dc.subject
USES
dc.subject
USER
dc.subject
TECHNICAL STANDARDS
dc.title
Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia
en
dc.type
Report
en
okr.crossref.title
Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia
okr.date.disclosure
2017-05-30
okr.doctype
Economic & Sector Work :: Other Health Study
okr.doctype
Economic & Sector Work
okr.docurl
http://documents.worldbank.org/curated/en/727671496171008743/Medicines-regulatory-systems-and-scope-for-regulatory-harmonization-in-Southeast-Asia
okr.googlescholar.linkpresent
yes
okr.identifier.doi
10.1596/26801
okr.identifier.externaldocumentum
090224b0843f6c9f_2_0
okr.identifier.internaldocumentum
26443563
okr.identifier.report
106526
okr.imported
true
okr.language.supported
en
okr.region.administrative
East Asia and Pacific
okr.region.country
Indonesia
okr.region.country
Malaysia
okr.region.country
Philippines
okr.region.country
Thailand
okr.region.country
Vietnam
okr.region.geographical
Southeast Asia
okr.sector
Health and other social services :: Health
okr.theme
Human development :: Health system performance
okr.topic
Health, Nutrition and Population :: Health Policy and Management
okr.topic
Health, Nutrition and Population :: Health Systems Development & Reform
okr.topic
Health, Nutrition and Population :: Pharmaceuticals & Pharmacoeconomics
okr.unit
Health, Nutrition & Population Global Practice

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