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

RELEASE DATE
22-Apr-2016
REGION
Asia Pacific
Research Code: P8A1-01-00-00-00
SKU: MX00001-AP-MR_16995

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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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Related Research
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.
More Information
No Index No
Podcast No
Author Liyana Nadiah
Industries Healthcare
WIP Number P8A1-01-00-00-00
Is Prebook No