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    Japan's Conditional Approval Pathway for Regenerative Medicines

    • 24 May 2018

    This article discusses the history, reasoning, legal decisions and subsequent regulatory requirements behind Japan's bid to become a world leader in regenerative medicine. The authors outline the process for seeking new regenerative product approvals through an accelerated regulatory pathway and spell out the oversight role played by Japan's regulatory authorities to enable new regenerative, cell-based therapies to be made available to the public in Japan as soon as possible, but with assurances of safety and efficacy.

  • Regulatory NewsRegulatory News

    FDA Issues Guidance on Maximal Usage Trials for OTC Drugs

    • 24 May 2018
    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance for drugmakers on the design and conduct of maximal usage trials for the purpose of adding a topical active ingredient to an over-the-counter (OTC) drug monograph.
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: ENVI Proposes Changes to HTA Cooperation Regulations

    • 24 May 2018
    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
  • Regulatory NewsRegulatory News

    Kickback Allegation Settlements Pile Up for Pharmaceutical Companies

    • 24 May 2018
    The Department of Justice (DOJ) on Thursday announced that Pfizer agreed to pay $23.85 million to resolve claims that it used a foundation as a conduit to help pay the copays of Medicare patients using three of its drugs. But Pfizer is just one of many pharmaceutical companies paying tens or even hundreds of millions to settle these allegations.
  • Feature ArticlesFeature Articles

    Regenerative Medicine Advanced Therapy Designations

    • 23 May 2018

    This article discusses recent legislative action regarding Regenerative Medicine Advanced Therapies (RMAT). The author describes the criteria RMAT candidate treatments must meet to apply for RMAT designation from the US Food and Drug Administration (FDA) and outlines the steps applicants must take to gain RMAT designation from FDA. She compares the processes and success rates for applying for and gaining RMAT designation to the processes and success rates for gaining "breakthrough therapy" designation.

  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Developing Anthrax Treatments

    • 23 May 2018
    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing drugs to protect against inhalation anthrax.
  • Regulatory NewsRegulatory News

    UK Prepping for Different Brexit Scenarios

    • 23 May 2018
    Sounding a note of optimism, the UK government released a report Wednesday calling again for the nation to remain a part of the European Medicines Agency (EMA) in some form, adding that “the prospect of a ‘no deal’ scenario is highly unlikely and therefore we are in a strong position from which to seek to agree a mutually beneficial way forward.”
  • Regulatory NewsRegulatory News

    Health Canada to Transition to Global Medical Device Nomenclature

    • 23 May 2018
    Health Canada announced Tuesday that it is initiating a transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), as part of a push to improve the availability, access to and quality of information available on medical devices in Canada.
  • Regulatory NewsRegulatory News

    EMA Begins Public Consultation on Draft Guideline for Handling and Shipping Investigational Medicines

    • 23 May 2018
    The European Medicines Agency (EMA) on Wednesday opened for consultation a guideline laying out the principles for managing investigational medicinal products for use in a clinical trial and in accordance with Good Clinical Practices (GCPs) and Good Manufacturing Practice (GMPs).

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China Regulatory Reform: An Update on Review Timelines and Drug Lag
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This article providesthree case studies with an assessment ofthe impact ofthe regulatory changes and insight intothe importance of including China in a global strategy for clinical development and drug registration.

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Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

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