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    Big Data and its Impact on the Pharmaceutical Industry

    This article defines “big data” and discusses its impact on the pharmaceutical industry regarding its application and usefulness. The author covers several areas in which big data has had a profound impact, such as in genomics, clinical trial monitoring, clinical monitoring and pharmacovigilance. He concludes by touching on big data and its relationship to the regulatory professional.   Introduction   The internet has provided a convenient way to share information ...
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    Regulatory Cybersecurity Requirements for Medical Devices

    This article discusses the relevance of cybersecurity to the healthcare industry, cybersecurity requirements presented by governing bodies and industry best practices for medical devices. Introduction Advancements in medical device technology has allowed for services, initiatives and changes in healthcare delivery to evolve at a break-neck pace. Smartphones are increasingly integrated into patient care planning, providing internet connectivity to share data with Heal...
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    The Continued Importance of Consumer Access to Chinese Medicine in a Changing Climate

    This article discusses the need for continued researcher access to Chinese medicinal herbs as the need for new options to treat febrile disease increases. The author cites global warming and climate change statistics as potentially responsible for the increase in tropical diseases for which traditional Chinese medicine has been used for centuries. She also reviews policies from various agencies that govern the use of such herbal medicines and supplements and concludes that...
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    Evolving Global Regulatory Landscape, Strategies and Best Practices

    October feature articles reported on a number of timely issues facing regulatory professionals today, including the advantages of using periodic safety update reports, practical solutions to pharmaceutical labeling challenges and best practices and strategies to manage global projects. Experts discussed a process to reform the medicinal products authorization system in China, illustrated the the need for regulatory requirements for ‘herbasimilars’ and introduced readers ...
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    Bundling Review for Active Pharmaceutical Ingredients, Excipients and Primary Packaging Materials in China

    This article discusses a new process for the approval of drugs in China called “bundling review.” The author describes the bundling review process, implemented by Chinese regulators in 2015, aimed at simplifying and accelerating the review of new drugs with previously approved active pharmaceutical ingredients, excipients and primary packaging materials. The author provides information contained in several annual regulatory updates to the 2015 guidance and highlights some ...
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    Global Regulatory Projects: Best Practices

    Global regulatory projects can be complex to manage. This article describes considerations and best practices in managing such projects.   Introduction   Global regulatory projects offer multiple layers of complexity. The differing regulatory requirements must be navigated, expert advice provided and volumes of information must be brought together in carefully planned logistical succession. The push and pull of global versus local regulatory needs, documentation of...
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    Botanical Drugs Herbal Equivalent: Herbasimilars

    Introduction   Botanicals will command the drug market only when researchers can quantify multidimensional analysis of a wholistic medicine.   More than 80 percent of the world population relies on plant-based medication. There are thousands of known and widely used herbal treatments in Traditional Chinese Medicine (TCM) and Ayurveda and 3,000 expert-accepted botanicals to treat cancer. Still, only two FDA approved botanicals are commercialized as drugs in the US...
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    Practical Solutions to Pharmaceutical Labeling Challenges

    This article discusses aspects of the labeling process important to ensuring product labels are accurate and consistent. The authors cover important aspects of labeling to keep labels up-to-date, to stay health authority-compliant and remain safe for patients. They review label information for both end-to-end and source-to-product labels as well as identify challenges and offer solutions regarding label version control, label proofing, tracking and inter-departmental commu...
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    Helen Brooke Taussig: An Often Overlooked Advocate for Drug Safety

    This article reviews the biography of Dr. Helen Brooke Taussig and discusses her successful efforts in the 1960s to prevent the drug “thalidomide,” the cause of wide-spread and serious birth defects in Europe, from being FDA-approved for use in the US. Introduction In the late 1950s and early 1960s, the drug thalidomide sent shock waves worldwide when it was proven that an allegedly harmless substance given to pregnant mothers as a sedative to combat morning sickness...
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    Are the periodic safety update reports a useful pharmacovigilance tool in the EU?

    This article discusses the importance of Periodic Safety Update Reports (PSURs) in the EU during drugs’ lifecycles. The author highlights the PSUR EU single assessment procedure, providing information on the stipulated timelines, what is published by the European Medicines Agency (EMA) and some aspects to be considered when writing a PSUR. A short reference is also made to the informal work-sharing procedure for follow-up for periodic safety update report single assessment...
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    Regulatory Strategies for EU MDR and EU IVDR Implementation

    September feature articles took an in-depth look at the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where global medical device leaders explored the nuances of the new requirements and answered the industry’s most challenging questions. Individual articles covered the implementation of the regulations into national legislation, what the new regulations mean for substance-based medical devices, how to incorporate clinical evaluation re...
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    What is Sufficient Clinical Evidence According to the MDR?

    This article evaluates what is considered “sufficient clinical evidence” and covers its important place in Medical Devices Regulation (MDR). The author defines sufficient clinical evidence and discusses the kinds of clinical evidence required by MDR and what evidence can be considered state-of-the-art. Equivalent devices and benchmark/similar devices are discussed as well as performance studies.   Introduction   Presenting sufficient clinical evidence is an importa...