ASEAN Pharmaceutical Regulatory Landscape

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.
Published: 22 Apr 2016

ASEAN Pharmaceutical Regulatory Landscape

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

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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