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    New method to an old approach: A semiquantitative approach for determining probability of regulatory success for ASEAN markets

    An objective assessment guide for estimating the likelihood of obtaining regulatory approval for marketing authorization applications submitted to local regulatory agencies is critical to facilitate commercial launch planning. In this paper, we describe a harmonized guide designed to estimate the probability of regulatory success (PRS) in the Association of Southeast Asian Nations (ASEAN). This guide focuses on a standardized set of criteria for semiquantitative assessment...
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    June’s Regulatory Focus: Nutrition in health and disease management, and the gut microbiome

    This issue marks the 6th annual RAPS series on nutrition in health and disease management, and the gut microbiome, in which global experts write about food, nutrition, and dietary supplements from regulatory, trade, marketing, and legal perspectives. In keeping with the series, articles in the current issue examine US Food and Drug Administration (FDA) regulatory guidance and requirements, especially regarding dietary supplements, bioengineered products, probiotics, and CO...
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    The ASEAN harmonization of technical standards on health supplements – An industry perspective

    Many countries in the Association of Southeast Asian Nations (ASEAN) require registration of health supplements, which generally takes a few months to years. There have been many different interpretations of the principle-based standards or regulations among the ASEAN member nations, making right-first-time regulatory submissions for the region hard to achieve and, absent defined review limits (such as rounds of questions/letters of deficiencies), lead times for approvals ...
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    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
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    Drug Development in Asia: Scattering the Mist

    This article discusses misconceptions and their causes, surrounding drug development in Asia, and explains the regions current drug development landscape. Introduction Asia is a huge landmass with contrasting physical and human geographies. The economic panorama within this rich milieu of human geography has become one of Asia's most prominent features, and many major pharmaceutical companies are acquainting themselves with the unique regulatory and medical landscape ...
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    The Southeast Asian Regulatory Environment for Pharmaceuticals: Part 2

    This article, the second in a two-part series on the Southeast Asian regulatory environment for pharmaceuticals, examines the regulatory landscape in Brunei, Vietnam, Laos, Myanmar (Burma) and Cambodia ( Table 1 ). Part one , published in December 2014, examined the larger ASEAN markets of Singapore, Malaysia, Indonesia, the Philippines and Thailand. 1 Table 1. Southeast Asian Pharmaceutical Markets 2–11 Countries Brunei Vietnam Laos Myanmar Cambod...
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    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...