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    eCTD Transition: Preparing for a Compliant Submission

    The electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements and reports to FDA's Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) for investigational new drug applications and drug master files. FDA's mandatory transitioning deadline for eCTD compliance is 5 May 2018. This article discusses what companies need to know to prepare a compliant submission under...
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    Biological Products and Biosimilars: Global Naming Debate

    This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety. Introduction Conventions and regulations for naming biosi...
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    The Evolving Role of the Regulatory Professional

    This article discusses the multifaceted role of regulatory professionals who must guide internal company functions from product formulation and analytical development, to manufacturing, supply chain, quality control, clinical and non-clinical science and statistics. The role includes understanding the changing regulatory environment, interpreting laws and regulations and generating relevant data to support compliance. Introduction The role of the regulatory profession...
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    eCTD: Journey Through the Decade

    This article discusses transitioning and implementing the electronic Common Technical Document (eCTD) in different regions a decade after its conceptualization. The article further discusses its impact on dossier compilation and document design practices as well as challenges faced by the pharmaceutical industry for effective lifecycle management . Overview The eCTD was developed in 2003 by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 E...