• Feature ArticlesFeature Articles

    US and EU Veterinary Medical Device Regulation

    This article describes regulatory efforts applied to veterinary medical devices in the US and EU and explores a small, descriptive sample of veterinary medical devices available on the US market to stimulate growth, innovation and dissemination throughout Europe. Introduction The effects of drugs and medical treatment in animals may vary from drug-to-drug and from species-to- species because of physiological and other species differences. In addition, the effectiveness ...
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    eCTD: A Global Regulatory Overview

    This article outlines the global status of electronic Common Technical Document (eCTD) and its implementation impact on companies. The author provides an international overview and focuses on regulatory eCTD submission requirements and global harmonization for medicinal products for human use in Canada, Europe, Japan and the US. Tips for organizing common technical documents are included. Introduction The electronic Common Technical Document (eCTD) is an international s...
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    Impact of the Revised EU Clinical Trial Regulation

    Clinical Trial Regulation EU No 536/2014 will come into effect in 2018. This article reports on aspects of the revised regulation and evaluates its potential impact on clinical trials conducted to assess medicinal products for human use. It discusses changes impacting the critical role of the Ethics Committees in the approval process for clinical trials as well as the planned, centralized data reporting channel, referred to as "the portal." While revisions to the regulat...