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  • Regulatory NewsRegulatory News

    Eudamed actor registration module set to launch in December

    In a position paper released Tuesday, the European Commission’s Medical Device Coordination Group (MDCG) confirmed that the Eudamed actor registration module will be deployed on 1 December 2020.   The module was previously expected in May, but its deployment was pushed back by the Commission just before its launch date to reflect the postponed date of application of Eudamed. At the time, the Commission said it would pursue a phased rollout of the six Eudamed modules ...
  • Regulatory NewsRegulatory News

    Australia’s TGA Issues Amended Nonclinical Studies Guidance

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued  an amended guidance on nonclinical studies for Module 4 of the  Common Technical Document  (CTD), which is an integral part of an application to register a prescription medicine on...
  • Regulatory NewsRegulatory News

    FDA Looks to Improve Generic Drug Submission Quality in New Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance document on the content and format of generic drug submissions using the common technical document (CTD). Background Generic drug applications are regulated under Section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , and are submitted to FDA using an Abbreviated New Drug Application (ANDA). A successful application will show that a drug is the same (as defined by FDA) as ...
  • 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...
  • 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...
  • CDRH Releases New Training Module for Guidance on Benefit-Risk Determinations

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new training module on a guidance document released by the agency that focuses on making benefit-risk determinations for medical device submissions. FDA's guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications , was released 27 March 2012. FDA noted at the time of the guidance release ...
  • Canada: New eCTD Guidance In Effect

    Health Canada issued Draft Guidance on 30 March on the Preparation of Drug Regulatory Activities in electronic Common Technical Documents (eCTDs). The guidance, which provides more options for sponsors of submissions, is effective immediately since it does not impose any new obligations. The exception to immediate effect-section 3.4.1 Module 1: Administrative and Product Information-will only be usable when the revised Canadian Module 1 Schema is published and adopted.&...
  • CDRH Releases New Learning Module on ISO 13485:2003

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released a new set of learning modules Friday on voluntary audit report submissions and how to utilize CDRH's new pilot program . The learning section consists of an introductory video and five learning modules in both English and French. The modules cover the following topics: GD211 - Welcome and Introduction by Dr. Jeff Shuren and Dr. Surpriya Sharma GD211 - Module 1...