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    Global Medical Device Cybersecurity Compliance Requirements

    This article discusses compliance requirements to maintain global medical device cybersecurity. The author provides examples of recent cybersecurity breaches and also reviews efforts made by regulatory agencies in the US, Australia and China to be proactive in encouraging better cybersecurity, offering tools and tips to help a variety of healthcare organizations to achieve better cybersecurity.   Introduction   Cybersecurity can be defined as a process for preventi...
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    Communication With the Chinese Center of Drug Evaluation (CDE) During Drug Development

    This article provides an English translation of the Chinese Center for Drug Evaluation’s (CDE’s) regulations for communication with CDE on meeting management practices. The author describes standard procedures for requesting, preparing for, scheduling, conducting, rescheduling/cancelling and documenting meetings or other correspondence with the agency.   Introduction   In October 2018, China’s national drug regulatory body, the National Medical Products Administrat...
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    Regulatory Intelligence: Update on Regenerative Medicine Advanced Therapies Designations

    This article discusses the scope and purpose of the special designation for Regenerative Medicine Advanced Therapies (RMAT) created by the passage of the 21 st Century Cures Act . The authors explain the benefits expected to be realized with RMAT, such as keeping the US globally competitive in the field. They provide a tally of products receiving the special designation to date and a current count, by year, of products for which RMAT designation has been requested.   ...
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    FDA’s Steps Toward a new Review Framework for Medical Devices Using Artificial Intelligence Algorithms

    This article provides a high-level overview of FDA’s proposed framework specifically tailored to promote the development of medical devices using artificial intelligence algorithms; it is not intended to provide a detailed explanation of the proposal, which is very technical.   Introduction   On 2 April 2019, the Food and Drug Administration (FDA) issued a statement by Commissioner Scott Gottlieb on steps toward a new review framework specifically tailored to pro...
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    The African Pharmaceutical and Medical Industry: Growth Factors

    Africa is one of the fastest growing economies in emerging markets. This article discusses some important aspects of this growing economy and how the local governments, as well as pharmaceutical companies can benefit from each other.   Introduction to Emerging Market   In the last two decades, various multinational pharmaceutical companies have entered and established themselves in one or more of the emerging markets. The Brazilian, Chinese and Indian markets grew ...
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    Biosimilars, Regulatory Science, Cell and Gene Therapy Guidance and China’s Regulatory Landscape

    April features took an in-depth look at biosimilars from a global perspective, the need to update regulatory science to include the use of Minimal Residual Disease (MRD), recent changes to China’s healthcare regulatory authorities and healthcare policy administration and the importance for manufacturers and regulators to ensure manufacturing controls are in place to sustainably produce regenerative medicines.   Biosimilars   Gowri Sukumar focuses on global regulati...
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    Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy Industry

    Addressing manufacturing controls for the cell and gene therapy industry, this article discusses criticality of establishing Chemistry Manufacturing Controls (CMC) Readiness, Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) for cell and gene therapy products. The author suggests manufacturers need sound drug development and manufacturing facility plans covering a product’s lifecycle and should establish sustainable manufacturing control strategies ...
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    Biosimilars: A Global Perspective

    This article focuses on global regulations emerging for biosimilar approval, the many challenges impacting the development of biosimilars and how various agencies define biologics, the evolution of guidances and data requirements for market approval, interchangeability and international nonproprietary names. The author provides an overview of the biosimilars that, over time, have been approved by regulators in various countries and regions.   Introduction   The ter...
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    Optimizing Clinical Trial Data to Support Biosimilars for Market Approval

    This article discusses the differences between biologics and biosimilars and focuses on their molecular dissimilarity. In covering efforts to gain market approval for biosimilars, the author reviews uncertainties associated with biosimilars, the value of pharmacokinetic data as well as therapeutic equivalence trials and their design. The author suggests the time is right for regulators and industry to engage in a critical evaluation of the clinical development of biosimila...
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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...