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    Similarity Approach for Complex Drugs: Biologics and Non-Biological Complex Drugs

    This article examines regulatory issues related to approvals of biosimilars and Non-Biological Complex Drugs (NBCDs) by both the European Medicines Agency and the US Food and Drug Administration with a focus on issues regarding similarity and bioequivalence. The authors suggest regulatory professionals should be aware of the new challenges for regulatory systems regarding these products as well as the clinical practice implications for substitution and interchangeability. ...
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    Chinese Health Policy and Regulatory Authorities Overview

    This article covers recent changes to China’s healthcare regulatory authorities and healthcare policy administration. The author explains the responsibilities and functions of the many government departments, agencies and regulatory bodies responsible for overseeing drugs, food, medical devices, testing and evaluation since the reorganization and restructuring of the former Chinese Food and Drug Administration (CFDA) and several other organizations in March 2018.   Intr...
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    Minimal Residual Disease as a Surrogate Endpoint for Product Development for Multiple Myeloma: Comparing FDA and EMA Guidances

    This article discusses the need to update regulatory science to include the use of Minimal Residual Disease (MRD) as a specific measure of tumor burden for multiple myeloma at levels undetectable through conventional laboratory techniques. The authors suggest MRD can potentially be used as a clinical and regulatory endpoint to evaluate a drug’s effect both on patients’ risk of future relapse risk and subsequent treatment survival outcomes, thus serving as a surrogate endpo...
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    Working with Other Markets: Pathways, Submissions and Strategies

    Feature articles in March explored working with other markets including global regulatory pathways in China, Japan and New Zealand, the regulation of animal drugs and veterinary medical devices and the complex regulatory pathway for drugs to treat orphan/rare pediatric diseases. Other articles explored risk management and medial device software.   Global Regulatory Pathways   Senior regulatory consultant, Yingying Liu , discusses Chinese pharmaceutical regulatory...
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    Veterinary Borderline Products, Veterinary Medical Devices and In Vitro Diagnostics: Global Regulatory Overview

    This article presents the regulatory framework for veterinary medical devices including examples and related guidelines for manufacturers and distributors within Europe and territories in Switzerland and the UK. It is a follow up to “US and EU Veterinary Medical Device Regulation.” 1 Introduction The previous article described regulatory efforts related to veterinary medical devices in the US and EU. It explored a small, descriptive sample of veterinary medical dev...
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    Regulatory Pathways for Orphan/Rare Pediatric Diseases: Global Overview

    This article discusses the regulatory pathways for orphan/rare pediatric diseases in China, Europe and Japan. While these regions do not have specific regulatory pathways for rare paediatric diseases as separate entities, the relevant paediatric regulations and pathways for approval are discussed. Topics include legislation, criteria for orphan drug designation and regulation, reviews and expedited pathways, incentives and advantages for applicants, such as exclusivity and...
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    Risk Management: A Difficult to Implement Regulatory Requirement

    This article describes the need for risk management in the healthcare industry from a personal viewpoint. It is an area always under development and there is a need for continued discussion and exchange of experiences.   Introduction   Over the last 10 to 15 years, especially with the publication of ICH Q9, risk assessment became a regulatory requirement in the pharmaceutical industry, as well as all areas of medical product development. 1-3 The concept is expandi...
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    Planning and Submission Considerations for Animal Drugs

    This article discusses the comprehensive planning and streamlining submission considerations by animal health companies that can decrease development cost and registration time for animal drugs. The planning and submission considerations are not limited to one country or region, but are for worldwide registration of the animal drug. The author covers regulatory pathway considerations, technical requirements and quality, safety and efficacy. The article does not cover vacci...
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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 ....