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  • Regulatory NewsRegulatory News

    CDISC Unveils New Standard for Clinical Trial Registries

    • 09 May 2016
    • By
    The new standard from the Clinical Data Interchange Standards Consortium (CDISC) will help industry generate submissions for multiple, global clinical trial registries, particularly those from the World Health Organization (WHO), European Medicines Agency (EMA) and ClinicalTrials.gov from a single file. The standard, known as the Clinical Trial Registry (CTR) XML, is inspired by the International Committee of Medical Journal Editors (ICMJE), and is based upon the 2...
  • FDA Adopts Four Changes to the eCTD Application

    The US Food and Drug Administration (FDA) has released revised and final versions of four documents intended to facilitate the submission of drug applications using the electronic common technical document ( eCTD ), a harmonized electronic submission standard used in the US, EU and Japan. Background The eCTD is a standard developed and implemented by the International Conference on Harmonisation (ICH), an international regulatory harmonization group focused on pharmaceu...
  • eCTD Revisions Published by FDA, Set for June 2014 Adoption

    In recent years, the electronic Common Technical Document (eCTD) has become the application type of choice for regulatory professionals operating in the US, EU, Japan and many other markets, offering them a relatively straightforward way to file small variations on a single application to multiple regulatory bodies. Now the US Food and Drug Administration (FDA) has announced the publication of final versions of several documents outlining specifications used in the eCTD's...
  • eCTD Update Provides Guidance on Use of Image Media in Application

    • 16 April 2013
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    The US Food and Drug Administration (FDA) has issued a new document outlining the process by which sponsors of drug applications should use the electronic Common Technical Document (eCTD), and in particular its file format types. Background The eCTD is a standard developed and implemented by the International Conference on Harmonisation (ICH), an international regulatory harmonization group focused on pharmaceutical and biological products. The standard is meant to stre...
  • FDA Wants New Study Data Exchange Format

    The US Food and Drug Administration (FDA) is calling for comments from industry and the public on the development of standards for study data exchange standards. In a 13 August 2012 Federal Register notice, FDA said it would be holding a meeting to assess the suitability of the current study data exchange format , the ASCII-based SAS Transport (XPORT) version 5 used by its drugs, biologics and devices regulatory centers. Though FDA said the standard has been in place ...
  • GHTF Releases Guidance on Adverse Event Data Reporting Standard

    The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final guidance document on its N54:2006 adverse event data reporting standard. The non-binding guidance document, N87: An XML Schema for the electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (NCAs) , wa...