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    The Chinese Pharmaceutical Market Today

    This article discusses recent pharmaceutical regulatory changes in China aimed at improving the speed of drug innovation, development and clinical trials testing in an effort to get drugs to Chinese patients faster. The author discusses the policy changes after the China Food and Drug Administration (CFDA) was renamed the National Medical Products Administration, (NMPA) and subsequently joined the International Council for Harmonization of Technical Requirements for Regist...
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    China’s New, Faster Marketing Authorization Approval Program

    This article discusses Chinese pharmaceutical regulatory issues from two perspectives: the regulatory organizational structure of the responsible government bodies and the regulatory legislative system. The author reviews changes initiated by the Chinese government aimed at manufacturing and marketing significantly more drugs and encouraging faster delivery of novel drug accessibility to patients in China. Topics include clinical trial review and approval, marketing author...
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    Is your software a medical device?

    Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, based on presentations from RAPS Regulatory Convergence, October 2018, explores whether and when computer software, used in a variety of ways in healthcare is a medical device. 1 The author reports on recent software and application regulations in both the European Union where...
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    Japan’s SAKIGAKE Designation System

    This article reviews the latest revision of Japan’s Pharmaceuticals, Medical Devices and other Therapeutic Products (PMD) Act and outlines the history and benefits of the SAKIGAKE designation system. The authors share details about the criteria for SAKIGAKE designation and the procedures and timing of SAKIGAKE designation.   PMD Act Revision History   Prior to 2013, the main regulation for medicines in Japan was called the Pharmaceutical Affairs Law or PAL ....
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    New Zealand’s New Regulatory Regime for Therapeutic Products

    This article discusses New Zealand’s efforts to update its current pharmaceutical regulatory legislation in place since the early 1980s. The author outlines many of the outdated provisions in the 1981 Medicines Act and the 1984 Medicines Regulation , provides a look at key changes built into the draft of the Therapeutics Products Bill (now open for comment until 18 April 2019) and presents a comprehensive table comparing the 1980s legislation and regulations to provisio...
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    Global Guidance, Medical Device Technology and Regulatory Intelligence

    February feature articles covered medical device technology challenges, artificial intelligence applications and regulatory intelligence strategy. Global experts also shared their experience on labeling activities for drugs and biologics, the future of the laboratory developed test (LDT) regulation, China’s new drug and device inspection regulations and new guidance for oncology drug development. Medical Device Technology Regulatory experts Stephen Amato and Net...
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    The Proposed VALID Act: A Possible Next Step in FDA’s Goal of Regulating LDTs

    This article discusses a Congressional draft proposal, The Verifying Accurate Leading-Edge IVCT Development (VALID) Act of 2018, aimed at making regulatory changes for Laboratory Developed Tests (LDTs). The authors identify a number of important points about the draft and offer analysis and commentary on proposed changes to classification and premarket review, pre-certification, registration and notification and appeals. They suggest that if the draft VALID Act became ...
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    Regulatory Labeling: Preparing for Launch

    This article discusses US labeling activities for drugs and biologics from postsubmission of a New Drug Application (NDA), Biologics License Application (BLA) or supplemental NDAs/BLA to approval. The author recommends useful FDA manuals and information as guides and covers labeling comments from FDA, team planning procedures, assigning team roles, responsibilities and timelines, negotiation processes and final approval.   Introduction   Pivotal studies have been c...
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    Impact of Innovative Healthcare Technologies: Regulatory Concerns of Ambulatory Cardiac Monitoring Devices

    This article provides an insight into the various types of Cardiac Monitoring Devices (CMD) available and their usefulness in remote cardiac monitoring for the early detection and treatment of arrhythmias. The article focuses on the technological innovations incorporated into these devices and the impact of this technology on the healthcare industry, regulatory challenges associated with their clinical utilization and potential solutions to those challenges.   Introduct...
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    Regulatory Intelligence Communication for Business Impact

    This article focuses on maximizing Regulatory Intelligence (RI) in response to specific stakeholder requests and offers best practices recommendations for RI communication. The authors provide an overview of information delivery methods and their applicability and present general considerations for communicating RI information by spreadsheets, text documents, slide presentations, strategy reports and competitive intelligence reports. They also highlight the use of due dili...
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    The Emerging Role of Artificial Intelligence in Healthcare

    This article discusses current and future Artificial Intelligence (AI) applications in healthcare and examines AI’s potential for adding efficiency to pharmaceutical research and medical practice as well as AI potentially providing better healthcare and patient outcomes, especially in terms of diagnostics and treatment. The author presents ethical concerns of AI applications, the potential for AI misuse and the case for developing ethical standards.   Introduction   ...
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    Risk Management Comes of Age. Have we?

    The first edition of the 2019 Regulatory Focus Article Series provides a much-needed comprehensive update on the emerging and evolving field of therapeutic risk management; and while bearing the title of ‘principles,’ this collection of articles also provides a long overdue review of many of the practices which have devolved from those principles.   What does it mean for a field to come of age?   Coming of age is a wonderful cultural concept, translated into col...