• Feature ArticlesFeature Articles

    China Food and Drug Administration Issues New Requirements for Clinical Trial Applications and New Drug Applications

    This article discusses the growth of China's pharmaceutical market, background of the global use and acceptance of the Common Technical Document (CTD), outlines the China Food and Drug Administration (CDFA) requirements for Clinical Trial Application (CTA) approval and New Drug Application (NDA) registration as critical steps in addressing drug quality, patient safety and shortening the time for access to new drugs. Introduction Earlier this year, the China Food and D...
  • Regulatory NewsRegulatory News

    Regulatory Focus Features Recap: July 2016

    Feature articles for July focused on managing regulatory information and systems and eCTD submissions. The regulatory industry is being challenged by the increasing complexity and rate of change associated with compliance related requirements, while also focusing on improving the efficiency of operations across the enterprise. For regulatory professionals, effective management of information and content is critical to managing interactions with health authorities on a ...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    Accelerating Global Submissions with a Six-Point eCTD Strategy

    This article discusses how an integrated, six-point electronic Common Technical Document (eCTD) publishing strategy can accelerate global submissions and enhance the efficiency of regulatory operations. In addition, it outlines challenges specific to: large companies with a well-established, eCTD-compliant publishing capacity, but may lack strategic agility; and smaller companies with limited eCTD resources and expertise. The World - and Sponsor Challenges - are Gettin...
  • Regulatory NewsRegulatory News

    FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics

    The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The 19-page specifications document describes FDA’s technical approach for submitting ICSRs, for incorporating regional terminology, and for adding ...
  • Regulatory NewsRegulatory News

    Streamlining the Regulatory Review Process in Pharma: The Upcoming Transition to Electronic Common Technical Documents

    • 13 January 2016
    [Editor's note: RAPS will be hosting an eCTD workshop 13-14 April. More details here .] Regulatory Focus Interviews Steve LoCastro and Sharen Johnson, West Pharmaceutical Services For pharmaceutical companies, filing Common Technical Documents (CTDs) is a critical aspect to the regulatory approval process. Historically, this process has been paper-centric until recently. This exclusive interview features a recent collaborative effort between West Pharmaceutical Ser...
  • Regulatory NewsRegulatory News

    FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

    Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...
  • Regulatory NewsRegulatory News

    Going Digital: EMA to Ditch Paper, Require Electronic Application Forms

    In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards. Going Digital The process of transitioning to electronic systems can be complicated, especially for regulatory processes which are often highly complex.  However, electronic documents provide a num...
  • Regulatory NewsRegulatory News

    ICH Takes Step Toward New eCTD Version

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) announced it has completed a step in the development of the next major version of the electronic Common Technical Document (eCTD). ICH’s M8 expert working group (EWG) has completed a draft of the implementation guide for ICH eCTD v4.0, the first major version change since v3.0 was adopted in 2003. Background ICH was formed followin...
  • Feature ArticlesFeature Articles

    Writing Regulatory Documents with E-Submissions in Mind

    Preparing regulatory documents for electronic submission (known as publishing) can be time consuming and complicated, whether the project is a small submission, such as a meeting request, or a new marketing application, and regardless of how well the content is written. Improper formatting can complicate the electronic submission preparation process further. Such documents require additional time and resources for publishing and potentially can result in costly subm...
  • Regulatory NewsRegulatory News

    FDA Releases New Electronic Submission Requirements for Biological Products

    A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) outlines a new process of submitting lot distribution reports (LDRs) in electronic format. Background As required by 21 CFR 600.81 , LDRs are used to update FDA regarding the quantity of a product distributed under an approved biologics license application (BLA). Those reports are required to be submitted at least every six months, though FD...
  • Regulatory NewsRegulatory News

    FDA Issues Revised Guidance on Electronic Drug Submissions

    The US Food and Drug Administration (FDA) has released a revised draft guidance document which instructs sponsors of pharmaceutical products on how to submit new product and trial applications using the electronic common technical document (eCTD) format. Background The document, first released in draft form in January 2013, describes new requirements passed under the Food and Drug Administration Safety and innovation Act (FDASIA) of 2012. The law, which contains a wi...