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  • Regulatory NewsRegulatory News
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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...
  • 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...
  • Regulatory NewsRegulatory News

    AHWP Finalizes Document Meant to Form Backbone of Software Regulation Approach

    The medical-device focused Asian Harmonization Working Group (AHWP) has released a new document meant to eventually help provide a common approach for the regulation of medical device software. The draft version of the document was released in July 2014, and provided a high-level overview of the regulatory approaches taken by major economies--the US, EU, Australia and China—toward the regulation of software as a medical device (SaMD). The overall goal of the white pa...
  • AHWP Unveils Four Guidance Documents Aimed at Regulation of IVDs

    The Asian Harmonization Working Party (AHWP), a medical device-focused regulatory harmonization group, has released an additional four documents for consultation and public comment, just days after releasing two other documents. Background AHWP is an international organization focused on harmonizing medical device regulation and policies across its 23 member countries. While those countries are primarily in Asia-China, India, Saudi Arabia, Singapore, etc-the group also ...
  • AHWP Looking to Expand Administrative Staff

    The Asian Harmonization Working Party (AHWP) is looking to expand their staff, according to minutes from the regulatory forum's 4 March Board of Directors meeting held in Hong Kong. AHWP is a medical device-focused regulatory forum that aims to promote greater regulatory harmonization in Asia, including China, India, Saudi Arabia, Pakistan, South Africa and Korea. The group's actions are carried out by a legal entity known as the AHWP Administrative Services Limited (AS...