Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia
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- an...
| Main Authors: | , , |
|---|---|
| Format: | Report |
| Language: | English en_US |
| Published: |
World Bank, Washington, DC
2017
|
| Subjects: | |
| Online Access: | http://documents.worldbank.org/curated/en/727671496171008743/Medicines-regulatory-systems-and-scope-for-regulatory-harmonization-in-Southeast-Asia http://hdl.handle.net/10986/26801 |
| id |
okr-10986-26801 |
|---|---|
| recordtype |
oai_dc |
| repository_type |
Digital Repository |
| institution_category |
Foreign Institution |
| institution |
Digital Repositories |
| building |
World Bank Open Knowledge Repository |
| collection |
World Bank |
| language |
English en_US |
| topic |
TAX INCENTIVES HARMONIZATION REGULATORY FRAMEWORK EXPORT MARKETS SUPERVISION EQUIPMENT ELECTRONIC DOCUMENT KNOWLEDGE SHARING CERTIFICATE VITAMINS MATERIALS LAWS TECHNICAL DOCUMENT MORBIDITY CAPABILITY VALUE CHAIN FINANCIAL RESOURCES INFORMATION MONITORING HEALTH CARE MARKET SHARES INFORMATION SHARING INTELLECTUAL PROPERTY RIGHTS HEALTH CAPACITY BUILDING HOLISTIC APPROACH PRICE VERIFICATION REGULATORY SYSTEMS PRODUCT INFORMATION FLOW OF GOODS MANAGEMENT SYSTEMS LEGAL BASIS MARKET ACCESS INFORMATION SYSTEMS PRODUCT DEVELOPMENT REGIONAL NETWORKS PUBLIC HEALTH LIFE EXPECTANCY COMPUTER RADIATION KNOWLEDGE NEW TECHNOLOGIES COMMUNICATIONS LEGAL FRAMEWORKS INSTITUTIONS HUMAN RESOURCE DATA ANALGESICS ADVERTISING TECHNICAL ASSISTANCE COMMERCE LEGISLATIVE FRAMEWORK PATIENTS PATIENT TECHNICAL DOCUMENTS ECONOMIC COOPERATION TECHNICAL COOPERATION LICENSE TARGETS BUSINESS NEEDS AGING GLOBALIZATION REGULATORY SYSTEM HEALTH MANAGEMENT MARKETING DRUG CONSUMPTION CONSULTANT STANDARDIZATION MATERIAL SCREENING INTERVIEW DATABASES MOVEMENT OF GOODS MORTALITY LEGAL FRAMEWORK CAPABILITIES TECHNICAL RESOURCES ACCESS TO INFORMATION MANUFACTURING TECHNOLOGY INTERNATIONAL STANDARDS R&D TECHNICAL INFRASTRUCTURE TECHNICAL RESOURCE SYSTEM DEVELOPMENT RELIABILITY TRAINING COURSES PROCUREMENT INSPECTION QUALITY MANAGEMENT GLOBAL MARKET BUSINESS PLAN INTERNATIONAL TRADE BEST PRACTICES RESULTS SURVEILLANCE MARKET PRICES TECHNICAL MEASURES REGULATORY REQUIREMENTS HEALTH POLICY CAPACITY-BUILDING MEDICAL DEVICES HEALTH OUTCOMES NETWORKS TECHNICAL EXPERTISE HYGIENE MANAGEMENT SYSTEM REGISTRATION APPLICATION PROTOCOLS DECISION MAKING PRIVATE SECTOR INSTITUTIONAL CAPACITY DOCUMENT MANAGEMENT WORKSHOPS SUPPLY CHAIN QUALITY CONTROL QUALITY OF LIFE MARKET SEGMENTS ADMINISTRATION INVENTION RESULT ELECTRONIC SUBMISSION CAPACITY BUILDING TRAINING GOVERNMENT POLICIES REGISTRATION APPLICATIONS E- COMMERCE COMMUNICABLE DISEASES CARDIOVASCULAR DISEASES SUPPLY CHAINS MARKET SHARE NETWORK BUSINESS BANDWIDTH BIOTECHNOLOGY HUMAN RESOURCES ISOLATION PERFORMANCE INSPECTIONS RETENTION COMPETITIVE PRICES BUSINESS PLANS INNOVATION CERTIFICATES INSTITUTION SITES PROFIT FUNCTIONALITY TECHNICAL REQUIREMENT WORLD TRADE TECHNICAL SUPPORT INTELLECTUAL PROPERTY DECISION MAKING PROCESS COMMUNICATION SUPPLY CHAIN MANAGEMENT NEW TECHNOLOGY STRATEGY RELIABLE ACCESS COMMODITIES INSTITUTIONAL FRAMEWORK REGISTRATION MEDICINES COMMUNICATION STRATEGY INSTITUTIONAL CAPACITIES DATABASE COUNTRY OF ORIGIN IP TIMELY ACCESS TECHNOLOGIES TECHNICAL REQUIREMENTS FINANCIAL CONSTRAINTS HEALTH SERVICES IMPLEMENTATION TARGET PRICES USES USER TECHNICAL STANDARDS |
| spellingShingle |
TAX INCENTIVES HARMONIZATION REGULATORY FRAMEWORK EXPORT MARKETS SUPERVISION EQUIPMENT ELECTRONIC DOCUMENT KNOWLEDGE SHARING CERTIFICATE VITAMINS MATERIALS LAWS TECHNICAL DOCUMENT MORBIDITY CAPABILITY VALUE CHAIN FINANCIAL RESOURCES INFORMATION MONITORING HEALTH CARE MARKET SHARES INFORMATION SHARING INTELLECTUAL PROPERTY RIGHTS HEALTH CAPACITY BUILDING HOLISTIC APPROACH PRICE VERIFICATION REGULATORY SYSTEMS PRODUCT INFORMATION FLOW OF GOODS MANAGEMENT SYSTEMS LEGAL BASIS MARKET ACCESS INFORMATION SYSTEMS PRODUCT DEVELOPMENT REGIONAL NETWORKS PUBLIC HEALTH LIFE EXPECTANCY COMPUTER RADIATION KNOWLEDGE NEW TECHNOLOGIES COMMUNICATIONS LEGAL FRAMEWORKS INSTITUTIONS HUMAN RESOURCE DATA ANALGESICS ADVERTISING TECHNICAL ASSISTANCE COMMERCE LEGISLATIVE FRAMEWORK PATIENTS PATIENT TECHNICAL DOCUMENTS ECONOMIC COOPERATION TECHNICAL COOPERATION LICENSE TARGETS BUSINESS NEEDS AGING GLOBALIZATION REGULATORY SYSTEM HEALTH MANAGEMENT MARKETING DRUG CONSUMPTION CONSULTANT STANDARDIZATION MATERIAL SCREENING INTERVIEW DATABASES MOVEMENT OF GOODS MORTALITY LEGAL FRAMEWORK CAPABILITIES TECHNICAL RESOURCES ACCESS TO INFORMATION MANUFACTURING TECHNOLOGY INTERNATIONAL STANDARDS R&D TECHNICAL INFRASTRUCTURE TECHNICAL RESOURCE SYSTEM DEVELOPMENT RELIABILITY TRAINING COURSES PROCUREMENT INSPECTION QUALITY MANAGEMENT GLOBAL MARKET BUSINESS PLAN INTERNATIONAL TRADE BEST PRACTICES RESULTS SURVEILLANCE MARKET PRICES TECHNICAL MEASURES REGULATORY REQUIREMENTS HEALTH POLICY CAPACITY-BUILDING MEDICAL DEVICES HEALTH OUTCOMES NETWORKS TECHNICAL EXPERTISE HYGIENE MANAGEMENT SYSTEM REGISTRATION APPLICATION PROTOCOLS DECISION MAKING PRIVATE SECTOR INSTITUTIONAL CAPACITY DOCUMENT MANAGEMENT WORKSHOPS SUPPLY CHAIN QUALITY CONTROL QUALITY OF LIFE MARKET SEGMENTS ADMINISTRATION INVENTION RESULT ELECTRONIC SUBMISSION CAPACITY BUILDING TRAINING GOVERNMENT POLICIES REGISTRATION APPLICATIONS E- COMMERCE COMMUNICABLE DISEASES CARDIOVASCULAR DISEASES SUPPLY CHAINS MARKET SHARE NETWORK BUSINESS BANDWIDTH BIOTECHNOLOGY HUMAN RESOURCES ISOLATION PERFORMANCE INSPECTIONS RETENTION COMPETITIVE PRICES BUSINESS PLANS INNOVATION CERTIFICATES INSTITUTION SITES PROFIT FUNCTIONALITY TECHNICAL REQUIREMENT WORLD TRADE TECHNICAL SUPPORT INTELLECTUAL PROPERTY DECISION MAKING PROCESS COMMUNICATION SUPPLY CHAIN MANAGEMENT NEW TECHNOLOGY STRATEGY RELIABLE ACCESS COMMODITIES INSTITUTIONAL FRAMEWORK REGISTRATION MEDICINES COMMUNICATION STRATEGY INSTITUTIONAL CAPACITIES DATABASE COUNTRY OF ORIGIN IP TIMELY ACCESS TECHNOLOGIES TECHNICAL REQUIREMENTS FINANCIAL CONSTRAINTS HEALTH SERVICES IMPLEMENTATION TARGET PRICES USES USER TECHNICAL STANDARDS Teo, Hui Sin Foerg-Wimmer, Christina Chew, Pei-Lyn Melissa Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia |
| geographic_facet |
East Asia and Pacific Southeast Asia Indonesia Malaysia Philippines Thailand Vietnam |
| description |
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. |
| format |
Report |
| author |
Teo, Hui Sin Foerg-Wimmer, Christina Chew, Pei-Lyn Melissa |
| author_facet |
Teo, Hui Sin Foerg-Wimmer, Christina Chew, Pei-Lyn Melissa |
| author_sort |
Teo, Hui Sin |
| title |
Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia |
| title_short |
Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia |
| title_full |
Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia |
| title_fullStr |
Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia |
| title_full_unstemmed |
Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia |
| title_sort |
medicines regulatory systems and scope for regulatory harmonization in southeast asia |
| publisher |
World Bank, Washington, DC |
| publishDate |
2017 |
| url |
http://documents.worldbank.org/curated/en/727671496171008743/Medicines-regulatory-systems-and-scope-for-regulatory-harmonization-in-Southeast-Asia http://hdl.handle.net/10986/26801 |
| _version_ |
1764462882010955776 |
| spelling |
okr-10986-268012021-05-25T09:00:29Z Medicines Regulatory Systems and Scope for Regulatory Harmonization in Southeast Asia Teo, Hui Sin Foerg-Wimmer, Christina Chew, Pei-Lyn Melissa TAX INCENTIVES HARMONIZATION REGULATORY FRAMEWORK EXPORT MARKETS SUPERVISION EQUIPMENT ELECTRONIC DOCUMENT KNOWLEDGE SHARING CERTIFICATE VITAMINS MATERIALS LAWS TECHNICAL DOCUMENT MORBIDITY CAPABILITY VALUE CHAIN FINANCIAL RESOURCES INFORMATION MONITORING HEALTH CARE MARKET SHARES INFORMATION SHARING INTELLECTUAL PROPERTY RIGHTS HEALTH CAPACITY BUILDING HOLISTIC APPROACH PRICE VERIFICATION REGULATORY SYSTEMS PRODUCT INFORMATION FLOW OF GOODS MANAGEMENT SYSTEMS LEGAL BASIS MARKET ACCESS INFORMATION SYSTEMS PRODUCT DEVELOPMENT REGIONAL NETWORKS PUBLIC HEALTH LIFE EXPECTANCY COMPUTER RADIATION KNOWLEDGE NEW TECHNOLOGIES COMMUNICATIONS LEGAL FRAMEWORKS INSTITUTIONS HUMAN RESOURCE DATA ANALGESICS ADVERTISING TECHNICAL ASSISTANCE COMMERCE LEGISLATIVE FRAMEWORK PATIENTS PATIENT TECHNICAL DOCUMENTS ECONOMIC COOPERATION TECHNICAL COOPERATION LICENSE TARGETS BUSINESS NEEDS AGING GLOBALIZATION REGULATORY SYSTEM HEALTH MANAGEMENT MARKETING DRUG CONSUMPTION CONSULTANT STANDARDIZATION MATERIAL SCREENING INTERVIEW DATABASES MOVEMENT OF GOODS MORTALITY LEGAL FRAMEWORK CAPABILITIES TECHNICAL RESOURCES ACCESS TO INFORMATION MANUFACTURING TECHNOLOGY INTERNATIONAL STANDARDS R&D TECHNICAL INFRASTRUCTURE PDF TECHNICAL RESOURCE SYSTEM DEVELOPMENT RELIABILITY TRAINING COURSES PROCUREMENT INSPECTION QUALITY MANAGEMENT GLOBAL MARKET BUSINESS PLAN INTERNATIONAL TRADE BEST PRACTICES RESULTS SURVEILLANCE MARKET PRICES TECHNICAL MEASURES REGULATORY REQUIREMENTS HEALTH POLICY CAPACITY-BUILDING MEDICAL DEVICES HEALTH OUTCOMES NETWORKS TECHNICAL EXPERTISE HYGIENE MANAGEMENT SYSTEM REGISTRATION APPLICATION PROTOCOLS DECISION MAKING PRIVATE SECTOR INSTITUTIONAL CAPACITY DOCUMENT MANAGEMENT WORKSHOPS SUPPLY CHAIN QUALITY CONTROL QUALITY OF LIFE MARKET SEGMENTS ADMINISTRATION INVENTION RESULT ELECTRONIC SUBMISSION CAPACITY BUILDING TRAINING GOVERNMENT POLICIES REGISTRATION APPLICATIONS E- COMMERCE COMMUNICABLE DISEASES CARDIOVASCULAR DISEASES SUPPLY CHAINS MARKET SHARE NETWORK BUSINESS BANDWIDTH BIOTECHNOLOGY HUMAN RESOURCES ISOLATION PERFORMANCE INSPECTIONS RETENTION COMPETITIVE PRICES BUSINESS PLANS INNOVATION CERTIFICATES INSTITUTION SITES PROFIT FUNCTIONALITY TECHNICAL REQUIREMENT WORLD TRADE TECHNICAL SUPPORT INTELLECTUAL PROPERTY DECISION MAKING PROCESS COMMUNICATION SUPPLY CHAIN MANAGEMENT NEW TECHNOLOGY STRATEGY RELIABLE ACCESS COMMODITIES INSTITUTIONAL FRAMEWORK REGISTRATION MEDICINES COMMUNICATION STRATEGY INSTITUTIONAL CAPACITIES DATABASE COUNTRY OF ORIGIN IP TIMELY ACCESS TECHNOLOGIES TECHNICAL REQUIREMENTS FINANCIAL CONSTRAINTS HEALTH SERVICES IMPLEMENTATION TARGET PRICES USES USER TECHNICAL STANDARDS 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. 2017-05-31T19:12:00Z 2017-05-31T19:12:00Z 2016 Report http://documents.worldbank.org/curated/en/727671496171008743/Medicines-regulatory-systems-and-scope-for-regulatory-harmonization-in-Southeast-Asia http://hdl.handle.net/10986/26801 English en_US CC BY 3.0 IGO http://creativecommons.org/licenses/by/3.0/igo World Bank World Bank, Washington, DC Economic & Sector Work :: Other Health Study Economic & Sector Work East Asia and Pacific Southeast Asia Indonesia Malaysia Philippines Thailand Vietnam |