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市場調查報告書

東南亞國協的醫藥品相關法律環境

ASEAN Pharmaceutical Regulatory Landscape

出版商 Frost & Sullivan 商品編碼 356996
出版日期 內容資訊 英文 112 Pages
商品交期: 最快1-2個工作天內
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東南亞國協的醫藥品相關法律環境 ASEAN Pharmaceutical Regulatory Landscape
出版日期: 2016年04月22日 內容資訊: 英文 112 Pages
簡介

本報告提供東南亞國協的醫藥品市場相關調查,各國的法律制度,產品報名手續,藥價法規,進口法規,智慧財產權等趨勢彙整。

第1章 摘要整理

第2章 馬來西亞

  • 法律制度
  • 產品分類
  • 產品登記
  • 產品登記評估方法
  • 清真醫藥品
  • 藥價法規
  • 進口法規
  • 外國投資
  • 競標制度
  • 採購
  • 智慧財產權:專利的保護
  • 智慧財產權:數據獨佔

第3章 泰國

  • 法律制度
  • 整體的法律規章
  • 製造投資法規
  • 合資企業必要條件
  • 產品登記
  • 進口法規
  • 外國藥物的進口法規
  • 藥價法規
  • 登記流程
  • 藥物分類
  • 智慧財產權

第4章 菲律賓

  • 法律制度
  • 產品登記
  • 藥價法規
  • 進口法規
  • 智慧財產權

第5章 印尼

  • 法律制度
  • 產品登記
  • 醫藥品的清真認證
  • 藥價法規
  • 進口法規
  • 製造必要條件
  • 智慧財產權

第6章 越南

  • 法律制度
  • 產品登記
  • 藥價法規
  • 進口法規
  • 智慧財產權

第7章 緬甸

  • 法律制度
  • 產品登記
  • 進口法規
  • 智慧財產權

第8章 柬埔寨

  • 法律制度
  • 產品登記
  • 進口法規
  • 智慧財產權

第9章 新加坡

  • 法律制度
  • 藥物分類
  • 產品登記
  • 藥價法規
  • 進口法規
  • 智慧財產權

第10章 汶萊

  • 法律制度
  • 產品登記
  • 進口法規
  • 智慧財產權

第11章 寮國

  • 法律制度
  • 產品登記
  • 藥價法規
  • 進口法規
  • 智慧財產權

第12章 附錄

第13章 Frost & Sullivan案例

目錄
Product Code: P8A1-01-00-00-00

Beginning the Journey Towards Harmonisation Post ASEAN Economic Community 2015

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 regulation, and IP rights.

Table of Contents

1. EXECUTIVE SUMMARY

  • Impact of AEC on the Healthcare Business in ASEAN
  • Regulatory Landscape
  • Regulatory Landscape (continued)
  • Regulatory Landscape (continued)
  • Regulatory Landscape (continued)
  • Regulatory Landscape (continued)

2. MALAYSIA

  • Regulatory Environment
  • Product Classification
  • Product Registration
  • Product Registration (continued)
  • Product Registration-Method of Evaluation
  • Product Registration
  • Product Registration (continued)
  • Halal Pharmaceuticals
  • MS 2424: 2012-Premises and Equipment
  • MS 2424: 2012-Halal Certificates
  • Pricing Regulation
  • Import Regulation
  • Foreign Investment in Malaysia
  • Public Tendering System
  • Public Tendering System-Procurement
  • IP Rights-Patent Protection
  • IP Rights-Data Exclusivity

3. THAILAND

  • Regulatory Environment
  • Thailand-General Regulations
  • Manufacturing Investment Restrictions
  • Joint Venture Requirement
  • Product Registration
  • Product Registration (continued)
  • Product Registration (continued)
  • Import Regulation
  • Restriction on Importation of Foreign Drugs
  • Pricing Regulation
  • Pricing Regulation (continued)
  • Registration Process-2 Steps
  • Drug Classification (3 Types)
  • IP Rights

4. THE PHILIPPINES

  • Regulatory Environment
  • Product Registration
  • Pricing Regulation
  • Import Regulation
  • Import Regulation (continued)
  • IP Rights

5. INDONESIA

  • Regulatory Environment
  • Product Registration
  • Product Registration (continued)
  • Halal Certification of Pharmaceuticals
  • Pricing Regulation
  • Import Regulation
  • Manufacturing Requirement
  • IP Rights

6. VIETNAM

  • Regulatory Environment
  • Regulatory Environment (continued)
  • Product Registration
  • Product Registration (continued)
  • Pricing Regulation
  • Import Regulation
  • Import Regulation (continued)
  • Import Regulation (continued)
  • Import Regulation (continued)
  • IP Rights

7. MYANMAR

  • Regulatory Environment
  • Regulatory Environment (continued)
  • Product Registration
  • Import Regulation
  • IP Rights

8. CAMBODIA

  • Regulatory Environment
  • Product Registration
  • Import Regulation
  • IP Rights

9. SINGAPORE

  • Regulatory Environment
  • Drug Classification
  • Product Registration
  • Product Registration (continued)
  • Product Registration (continued)
  • Pricing Regulation
  • Import Regulation
  • IP Rights
  • IP Rights (continued)

10. BRUNEI

  • Regulatory Environment
  • Product Registration
  • Import Regulation
  • IP Rights

11. LAOS

  • Regulatory Environment
  • Product Registration
  • Product Registration (continued)
  • Pricing Regulation
  • Import Regulation
  • IP Rights

12. APPENDIX

  • Legal Disclaimer

13. THE FROST & SULLIVAN STORY

  • The Frost & Sullivan Story
  • Value Proposition: Future of Your Company & Career
  • Global Perspective
  • Industry Convergence
  • 360° Research Perspective
  • Implementation Excellence
  • Our Blue Ocean Strategy
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