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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...
  • 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...
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    US, Canada Continue to Push for Regulatory Harmonization in the Life Sciences

    US and Canadian regulators are continuing to work together to harmonize the way in which they regulate pharmaceuticals, biologics, over-the-counter drugs, medical devices and veterinary products, both governments confirmed in an update this week. Background Both governments' efforts come from a 2012 regulatory initiative known as the Regulatory Cooperation Council (RCC), whose stated goal is to increase regulatory cooperation between both countries. That cooperation, ...
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    IMDRF Moves Forward With Effort to Standardize Global Device Submissions

    The International Medical Device Regulators Forum (IMDRF) has released two final documents that, once implemented, should make it much easier to get medical device products approved in multiple regions, including the US, EU and Canada. Background IMDRF launched in 2012 as the regulators-only successor to the Global Harmonization Task Force (GHTF), which disbanded in December 2012 after its device regulatory members decided to split off and form their own juncture withou...
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    Health Canada, SwissMedic Join ICH as Steering Committee Members

    The International Conference on Harmonization (ICH), the influential international pharmaceutical regulatory harmonization body, has elected to add two new regulators to its Steering Committee, the group has announced. In an announcement on 8 July 2014, ICH said Health Canada (HC) and Swiss regulator SwissMedic would both be joining its Steering Committee "in recognition of their historical involvement and commitment to ICH." The Steering Committee, which previously onl...
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    Medical Device Industry and Regulator Harmonization Efforts Update

    Introduction As more countries formalize medical device regulations, international regulatory and quality systems professionals must continually refine and harmonize their internal processes for registration of medical device products and adherence to international quality standards. Although premarket registration and quality systems are often the responsibility of separate departments, they are intertwined, and these departments should work closely together. A regulato...
  • As Oceanic Regulator ANZTPA Comes Online, Harmonization Efforts Yield Results

    The regulatory systems of Australia and New Zealand have been slowly merging over the last few years, with the stated end goal of being able to provide better regulatory services at a lower cost to the taxpayers of each respective country. The Australia New Zealand Therapeutic Products Agency (ANZTPA), as the merged agencies will be called, has slowly been making note of its milestones over the last few years as it builds its regulatory capacities up and out. In Septe...
  • IMDRF Asks for Industry Input on Device Harmonization

    Members of the medical device industry will soon get a chance to guide the development of global medical device regulation, if only for a day. Background In a notice sent to members of the device industry on 27 January 2014, the US Food and Drug Administration (FDA) said it and fellow members of the International Medical Device Regulators Forum (IMDRF) will soon be holding a day-long stakeholders meeting. For IMDRF, this isn't a small deal. The group is the successor t...
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    Looking to the Future in Regulatory Affairs

    Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and expectations, and discussions with peers in the regulatory community. There are many strands to consider when looking to the future in regulatory affairs. The first strand is the regulations and how these are likely to be impacted by a globalized ...
  • 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 ...
  • Australia, New Zealand Launch Next Phase of Regulatory Harmonization Effort

    Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe)  announced on 13 November 2013 the next stage of their joint efforts toward regulatory harmonization and the launch of a joint regulatory agency, the Australia New Zealand Therapeutic Products Agency (ANZTPA).. This new phase of joint work will cover the next two and a half years and targets 14 activities across the following six regul...
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    Summary Technical Documentation (STED): Harmonizing a Predictable Regulatory Submission

    • 26 September 2013
    Practical experience harmonizing global submissions today is somewhat limited. However, harmonizing regulatory approval processes may benefit from industry participation and further activities to promote a standardized format for medical device submissions. The Japan-US "Harmonization-By-Doing" (HBD) Pilot Program was launched in December 2003 to develop harmonized clinical trials and clinical trial requirements between Japan and the US along with a focus on regulatory co...