• 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    The US Food and Drug Administration (FDA) has released a new draft guidance document on the content and format of generic drug submissions using the common technical document (CTD).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 ...
  • Regulatory NewsRegulatory News

    FDA Releases New Study Format Validation Rules

    The US Food and Drug Administration (FDA) has released a new document intended to provide a recommended approach for submitting study data for drugs and biological products using the Standard for Exchange of Nonclinical Data (SEND) standard. Background FDA accepts—and plans to require—submissions of drug products using electronic data submission formats adhering to accepted standards of formatting. The appropriate use of those standards will soon be of critical importa...
  • 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...
  • PhRMA, BIO Express Unanimous Concerns About FDA Electronic Submission Guidance Docs

    Two of the pharmaceutical industry's largest trade groups are weighing in on the US Food and Drug Administration's (FDA) proposal to digitize the drug application submission process, saying the agency is generally on-point, but needs to clarify a few outstanding issues. Background In 2012, the  Food and Drug Administration Safety and Innovation Act ( FDASIA ) was passed into law, and with it a provision mandating that all applications submitted under Section 5...
  • Australian Regulators Launch Electronic Submission System for Pharmaceuticals

    Australian regulators with its Therapeutic Goods Administration (TGA) have announced that they will soon adopt an electronic system capable of receiving drug applications without the use of paper. Background TGA first announced its intent to move forward with the transition in October 2013. At present, TGA receives all of its submissions in paper format, which is expensive for industry to create and regulators to store. New drug applications can be tens, and often hun...
  • FDA Unveils New Changes to eCTD Submission Formats

    If you weren't paying attention closely late last week, you might easily have missed a small but important announcement made by the US Food and Drug Administration (FDA). By the end of 2014, it says, it expects to be able to receive submissions referencing version 3.1 of the electronic Common Technical Document ( eCTD )-a change that will primarily affect regulated pharmaceutical marketing. Pharmaceutical Marketing Changes The announcement, made on its eCTD Validation ...
  • 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...
  • EMA to Phase out Support for Non-Electronic Submissions in 2014

    The European Medicines Agency (EMA) has announced that its eSubmission Gateway will become mandatory for all electronic common technical document (eCTD) submissions made to the agency through the centralised procedure starting in May 2014. Background The eCTD is a standardized document format used around the world for the submission of pharmaceutical products, and uses a module approach to organize data in a way that makes submissions acceptable to a wide range of reg...
  • New FDA Policy Updates, Clarifies Process of Moving to Electronic Submission Forms

    The US Food and Drug Administration (FDA) has released a new manual of policies and procedures (MAPP) for its internal drug regulatory staff regarding the creation and maintenance of its electronic submissions docket, the system that dictates how pharmaceutical and biotechnology companies submit applications to the agency. The MAPP, Maintaining CDER's Electronic Submissions Docket , regards the more practical aspects of 21 CFR 11, which permits the Center for Drug E...
  • eCTD Update Provides Guidance on Use of Image Media in Application

    • 16 April 2013
    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...
  • Health Canada Moving to Electronic Only Format

    Health Canada has announced that as of 1 June 2013, all "administrative regulatory" submissions must be in electronic format only, submitted either as an electronic common technical document (eCTD) or a Portable Document Format (PDF) file.  Submissions in eCTD format must be used for labeling documents such as product monographs, and are preferred for other regulatory submissions. The electronic submission must include a cover letter, in both electronic and ...
  • PhRMA, BIO, GSK Call on FDA to Alter eCTD Draft Guidance

    Some of the largest entities in the pharmaceutical industry, including pharmaceutical manufacturer GlaxoSmithKline and industry trade groups BIO and PhRMA, are weighing in on a recent draft guidance published by US regulators, saying minor changes are needed to reflect the clarity of the guidance and its lifespan. Background Their comments reference a 3 January 2013 draft revision of guidance for industry that would require all new drug applications (NDAs), abbreviate...