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  • Feature ArticlesFeature Articles

    Thailand's Approach to Drug Quality Assurance: Creation of the Green Book

    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. Regulatory System Overview Thailand's health system is regulated by the MOPH and the Thai FDA in collaboration with a number of government and independent health agencies. The MOPH is responsible for all health-relate...
  • Regulatory NewsRegulatory News

    Drug Manufacturer Lacked Adequate Controls Over Manufacturing, FDA Warns

    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. In a 27 February 2015 Warning Letter to Novacyl Ltd, FDA references an April 2014 inspection of the company's Samukprakam, Thailand manufacturing facility. There, FDA said it "identifi...
  • Feature ArticlesFeature Articles

    The Southeast Asian Regulatory Environment for Pharmaceuticals (Part 1)

    This 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 ASEAN markets of Singapore, Malaysia, Thailand, the Philippines and Indonesia. Part 2 will discuss Brunei, Vietna...