• Electronic CTD Document Updates to Now Allow Information about Medical Devices, FDA Says

    US Food and Drug Administration (FDA) officials have announced the availability of newly revised final documents that describe the recommended process for regulatory professionals to use when submitting electronic versions of the Common Technical Document (eCTD), including a curious update regarding the submission of information on medical device submissions. Background The eCTD is a standard developed and implemented by the International Conference on Harmonisation (...
  • FDA Signs onto ICH Guidance on E3 Guideline

    The US Food and Drug Administration (FDA) has released a new final guidance for industry explaining the E3 Structure and Content of Clinical Study Reports guideline , part of ongoing efforts by regulators to clarify some of the more common questions and answers about the longstanding guideline. The E3 guideline was approved by the International Conference on Harmonisation (ICH) in 1995, and adopted by FDA on 17 July 1996. It describes how sponsors can compile a ...
  • EMA Launches Full eCTD Submission Platform for Human Medicines Applications

    The European Medicines Agency (EMA) has launched its eSubmission Gateway and a new eSubmission web client for the submission of applications for human medicines, it announced on 15 January 2013. The eSubmission platform allows for the submission of the electronic common technical document, a harmonized, tiered submission format that allows for easier submissions across multiple geographic regions. The release II update to the gateway "allows applicants to submit doc...
  • In Shift, FDA to Require eCTD for all NDA, ANDA, BLA and IND Submissions

    • 03 January 2013
    A long-awaited draft guidance requiring the submission of most pharmaceutical and biological product applications to be done using the electronic common technical document (eCTD) standard has been released by the US Food and Drug Administration (FDA). The 3 January 2012 release of the document, Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using ...
  • FDA Announces Adoption of ICH's Q11 Manufacturing Guideline

    The US Food and Drug Administration (FDA) has announced its adoption of the International Conference on Harmonization's Q11 guideline on the development and manufacture of biological and chemical drugs. The guideline, Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological Biological Entities , was released by ICH on 1 May 2012 for voluntary adoption by worldwide regulators. Explained FDA in its Federal Register posting announc...
  • Australia to Launch Consultation on Development of eCTD Guidelines, Timetable

    Australia's Therapeutic Goods Administration (TGA) is preparing to establish procedures, guidelines and a timetable for the implementation of the submission of medicine applications using the electronic Common Technical Document (eCTD), it announced on 9 October. The eCTD is an electronic, module-based regulatory application format developed and maintained by the International Conference on Harmonisation (ICH). The basic premise of the eCTD is to harmonize the layout a...
  • Health Canada Overhauls Guidance for eCTD Module

    Health Canada has released a new guidance document pertaining to the creation of the Canadian Module 1 backbone of the electronic Common Technical Document (eCTD), a standardized pharmaceutical review application format created by the International Conference on Harmonisation (ICH). Canadian regulators explained that the new guidance replaces an earlier 2004 guidance of a similar name, and outlines the process by which industry can create a regional backbone file. The fi...
  • 'Major Updates' to eCTD Module 1 Released by FDA

    The US Food and Drug Administration (FDA) has announced the release of "major updates" to Module 1 of the electronic common technical documents (eCTD), used to supplement all eCTD submissions in the US with specific information required by FDA. The two documents, The eCTD Backbone Files Specification for Module 1, version 2.0 and Comprehensive Table of Contents Headings and Hierarchy, version 2.0. , are available on FDA's website along with other supporting tec...
  • EU Regulators Expand Electronic Submission Program, Recommend Wider Use

    After a four-month pilot period, EU regulators are proposing to make permanent a program that allows applicants and sponsors of marketing authorization applications to submit their entire dossiers electronically. The European Medicines Agency's (EMA) 27 July statement on continuing the electronic application form (eAF) pilot program says the testing phase was "successful," and use of the program will allow sponsors and applicants to better control the quality and consist...
  • EMA to Applicants: Go Digital--and Don't Forget Croatia

    • 06 July 2012
    The European Medicines Agency (EMA) has two messages for applicants of marketing authorization applications: please submit all applications electronically, and don't forget to submit labeling translations to Croatian regulatory authorities. In a statement released 5 July, EMA said it is imploring sponsors of pharmaceutical products to start taking advantage of its electronic application forms, including its eSubmission Gateway, due to its relative ease of use. The ag...
  • Health Canada Finalizes eCTD Guidance

    Regulators at Health Canada have announced the finalization of guidance intended to assist sponsors in preparing electronic common technical documents (eCTDs) to submit their pharmaceutical dossiers to the agency. Health Canada said in April 2012 it is moving entirely to an eCTD format for all applications of pharmaceutical products after the non-eCTD applications were seen as a burden on the agency. "Health Canada is considering ending the Non-eCTD Hybrid Pilot at the e...
  • FDA Announces Planned Update to Electronic Common Technical Document

    The US Food and Drug Administration (FDA) announced its intent to hold a meeting to update stakeholders on the changes it plans to make to Module 1 of the Electronic Common Technical Document (eCTD), which is used to describe administrative and prescribing information for medicines. The eCTD is a standardized application form developed in conjunction with the International Conference on Harmonization (ICH) and its member parties. Both the Center for Drug Development and ...