• 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...
  • Feature ArticlesFeature Articles

    Northern Africa: Regulatory Submission Considerations for the Region

    Northern Africa is an emerging region that presents a unique and diverse set of regulatory considerations . Through the World Health Organization (WHO), US Food and Drug Administration (FDA) and European Medicines Agency (EMA), sponsors have been able to leverage the regulatory review and approval of medicines in International Conference on Harmonization (ICH) countries to access drugs to treat major diseases. While some of these regulatory pathways, including the...
  • Feature ArticlesFeature Articles

    21 CFR Part 11: The Ins and Outs of One of FDA's Most Difficult Rules

    Introduction 1992 was a different time, when the Internet was still in its infancy and email as a corporate tool was only just beginning to take hold. In the life science industry, there were dreams—then unrealized—of a completely electronic and totally paperless office. And at the US Food and Drug Administration (FDA), regulators were only just beginning to realize the potential effects digital data management systems could have on product development. It was around th...
  • 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

    With New Rule in Place, FDA Establishes Procedures for Submitting Vaccine Safety Problems

    A new draft guidance document issued this week by the US Food and Drug Administration (FDA) establishes best practices for the submission of safety reports related to the use of vaccines. Background FDA has since 2009 been advocating for a rule which would require all mandatory postmarketing safety reports to be submitted to the agency in electronic form (instead of paper), saying that the change could allow it to better process, review and archive the documents. The r...
  • Regulatory NewsRegulatory News

    FDA Unveils Fixes, Enhancements to its eSubmitter System

    The US Food and Drug Administration's (FDA) device and biologics review divisions have made several small enhancements and fixes to the eSubmitter system, the agency's electronic system for receiving, filing and tracking product submissions. The eSubmitter system is currently used by the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH), as well as FDA's veterinary and tobacco divisions. Both CDRH an...
  • 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 ...
  • 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...
  • Feature ArticlesFeature Articles

    The Five Stages of Submissions

    • 01 April 2014
    Sometimes you've just got to get it off your chest. This article is a humorous take on the regulatory submissions process and the drama it can entail for the regulatory team. Elisabeth Kübler-Ross identified the five stages of grief as denial, anger, bargaining, depression and acceptance. Regulatory submissions are really no different. First comes a proposed submission date from management. It is clearly impossible. Surely that is apparent to all involved. It's ...