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ASEAN Pharmaceutical Regulatory Landscape
ASEAN Pharmaceutical Regulatory Landscape
ASEAN Economic Community (AEC) to Push Free Flow of Goods, Services and Investments, Creating $160 Billion Opportunity
22-Apr-2016
Asia Pacific
$3,000.00
Special Price $2,250.00 save 25 %
Description
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
Impact of AEC on the Healthcare Business in ASEAN
Regulatory Landscape
Regulatory Landscape (continued)
Regulatory Landscape (continued)
Regulatory Landscape (continued)
Regulatory Landscape (continued)
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
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
Regulatory Environment
Product Registration
Pricing Regulation
Import Regulation
Import Regulation (continued)
IP Rights
Regulatory Environment
Product Registration
Product Registration (continued)
Halal Certification of Pharmaceuticals
Pricing Regulation
Import Regulation
Manufacturing Requirement
IP Rights
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
Regulatory Environment
Regulatory Environment (continued)
Product Registration
Import Regulation
IP Rights
Regulatory Environment
Product Registration
Import Regulation
IP Rights
Regulatory Environment
Drug Classification
Product Registration
Product Registration (continued)
Product Registration (continued)
Pricing Regulation
Import Regulation
IP Rights
IP Rights (continued)
Regulatory Environment
Product Registration
Import Regulation
IP Rights
Regulatory Environment
Product Registration
Product Registration (continued)
Pricing Regulation
Import Regulation
IP Rights
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Popular Topics
| No Index | No |
|---|---|
| Podcast | No |
| Author | Liyana Nadiah |
| Industries | Healthcare |
| WIP Number | P8A1-01-00-00-00 |
| Is Prebook | No |