ASEAN Pharmaceutical Regulatory Landscape

  • ID: 3699175
  • Report
  • Region: ASEAN
  • 112 Pages
  • Frost & Sullivan
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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.

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1. Executive Summary
  • Impact of AEC on the Healthcare Business in ASEAN
  • Regulatory Landscape
2. Malaysia
  • Regulatory Environment
  • Product Classification
  • Product Registration
  • Product Registration-Method of Evaluation
  • Product Registration
  • 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
  • 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
  • IP Rights
5. Indonesia
  • Regulatory Environment
  • Product Registration
  • Halal Certification of Pharmaceuticals
  • Pricing Regulation
  • Import Regulation
  • Manufacturing Requirement
  • IP Rights
6. Vietnam
  • Regulatory Environment
  • Product Registration
  • Pricing Regulation
  • Import Regulation
  • IP Rights
7. Myanmar
  • Regulatory Environment
  • Product Registration
  • Import Regulation
  • IP Rights
8. Cambodia
  • Regulatory Environment
  • Product Registration
  • Import Regulation
  • IP Rights
9. Singapore
  • Regulatory Environment
  • Drug Classification
  • Product Registration
  • Pricing Regulation
  • Import Regulation
  • IP Rights
10. Brunei
  • Regulatory Environment
  • Product Registration
  • Import Regulation
  • IP Rights
11. Laos
  • Regulatory Environment
  • Product Registration
  • Pricing Regulation
  • Import Regulation
  • IP Rights
12. Appendix
  • Legal Disclaimer
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