Thailand's Approach to Drug Quality Assurance: Creation of the Green Book
By Thanita Patthamajinda, RPh -
Published 27 April 2017
This article discusses how Thailand's Ministry of Public Health (MOPH), Food and Drug Administration (Thai FDA) and a number of government and independent health agencies regulate drugs, both new and generic, as well as traditional, nonwestern medicines.
Categories: Features, Asia, Drugs, Quality
Tags: Thailand, Green Book, Quality Assurance
Drug Manufacturer Lacked Adequate Controls Over Manufacturing, FDA Warns
By Alexander Gaffney, RAC -
Published 11 March 2015
A Thailand-based active pharmaceutical ingredient (API) manufacturer has been warned by the US Food and Drug Administration (FDA) for failing to ensure that its manufacturing data could not be altered or falsified—claims similar to those levied against many Indian pharmaceutical companies.
Categories: News, US, CDER, Active pharmaceutical ingredients, Compliance, Manufacturing
Tags: Thailand, Data Integrity, CGMP
The Southeast Asian Regulatory Environment for Pharmaceuticals (Part 1)
By Ravi Varahalu and Jairam Masetti -
Published 03 December 2014
A two-part series on the Southeast Asian regulatory environment for pharmaceuticals describes the regulatory landscape in each of the 10 Association of Southeast Asian Nations (ASEAN) countries and attempts to capture some of the key elements that companies should consider when planning to enter ASEAN markets. Part 1 presents information on the larger markets of Singapore, Malaysia, Thailand, the Philippines and Indonesia. Part 2 will discuss Brunei, Vietnam, Laos, Myanmar (Burma) and Cambodia.
Categories: Features, Asean, Distribution, Drugs, Submission and registration
Tags: ASEAN, pharmaceuticals, Asian markets, regulatory review, Singapore, Malaysia, Thailand, Philippines, Indonesia, harmonization