ASEAN Pharmaceutical Regulatory Landscape

ASEAN Economic Community (AEC) to Push Free Flow of Goods, Services and Investments, Creating $160 Billion Opportunity

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This study aims is to analyse the ASEAN pharmaceutical regulatory landscape in terms of the ease of doing business, the impact of harmonisation post AEC 2015, and the key factors and dynamics influencing member countries and the outside world. It also provides strategic recommendations for market participants and conclusions. An overview of the regulatory environment of each country in ASEAN and a comparison of ease of entry into these countries based on regulatory environment attractiveness are also given. The study provides an in-depth understanding of the following topics: general regulatory environment, product registration—process flow, cost of registration, and timeline, pricing regulation, import regul

Table of Contents

Executive SummaryImpact of AEC on the Healthcare Business in ASEANRegulatory LandscapeRegulatory Landscape (continued)Regulatory Landscape (continued)Regulatory Landscape (continued)Regulatory Landscape (continued)MalaysiaRegulatory EnvironmentProduct ClassificationProduct RegistrationProduct Registration (continued)Product Registration—Method of EvaluationProduct RegistrationProduct Registration (continued)Halal PharmaceuticalsMS 2424: 2012—Premises and EquipmentMS 2424: 2012—Halal CertificatesPricing RegulationImport RegulationForeign Investment in MalaysiaPublic Tendering SystemPublic Tendering System—ProcurementIP Rights—Patent ProtectionIP Rights—Data ExclusivityThailandRegulatory EnvironmentThailand—General RegulationsManufacturing Investment RestrictionsJoint Venture RequirementProduct RegistrationProduct Registration (continued)Product Registration (continued)Import RegulationRestriction on Importation of Foreign DrugsPricing RegulationPricing Regulation (continued)Registration Process—2 StepsDrug Classification (3 Types)IP RightsThe PhilippinesRegulatory EnvironmentProduct RegistrationPricing RegulationImport RegulationImport Regulation (continued)IP RightsIndonesiaRegulatory EnvironmentProduct RegistrationProduct Registration (continued)Halal Certification of PharmaceuticalsPricing RegulationImport RegulationManufacturing RequirementIP RightsVietnamRegulatory EnvironmentRegulatory Environment (continued)Product RegistrationProduct Registration (continued)Pricing RegulationImport RegulationImport Regulation (continued)Import Regulation (continued)Import Regulation (continued)IP RightsMyanmarRegulatory EnvironmentRegulatory Environment (continued)Product RegistrationImport RegulationIP RightsCambodiaRegulatory EnvironmentProduct RegistrationImport RegulationIP RightsSingaporeRegulatory EnvironmentDrug ClassificationProduct RegistrationProduct Registration (continued)Product Registration (continued)Pricing Regulation Import RegulationIP RightsIP Rights (continued)BruneiRegulatory EnvironmentProduct RegistrationImport RegulationIP RightsLaosRegulatory EnvironmentProduct RegistrationProduct Registration (continued)Pricing RegulationImport RegulationIP RightsAppendixLegal DisclaimerThe Frost & Sullivan StoryThe Frost & Sullivan StoryValue Proposition: Future of Your Company & CareerGlobal PerspectiveIndustry Convergence360º Research PerspectiveImplementation ExcellenceOur Blue Ocean Strategy

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