• Feature ArticlesFeature Articles

    Navigating the maze of electronic submissions at EMA

    The European Medicines Agency (EMA) facilitates a range of different submissions and application processes using several submission systems for electronic procedures, which have clear advantages over paper-based submissions. At present, first-time applicants cannot proceed with a regulatory submission unless they have set up several accounts and assigned roles and registered their companies and their assets. However, there is no “one-stop-shop” place on the EMA website for...
  • Regulatory NewsRegulatory News

    Swissmedic To Prioritize Electronic Adverse Events Reports

    Swiss drug regulator Swissmedic on Monday announced it will begin prioritizing the review of electronically submitted adverse drug reaction (ADR) reports in light of a recent influx of such reports. According to Swissmedic, the number of ADRs received has grown in recent years, driven primarily by growth in the number of reports submitted by drugmakers. The agency also says it expects the upward trend to continue, in part due to the recent revision to Switzerland's Ther...
  • Feature ArticlesFeature Articles

    Race to Comply with FDA ESG Guidelines

    For life sciences companies, paper-based commercial material submissions do not cut it anymore, not only when it comes to automating processes for improved efficiency, but also in the face of rapidly approaching new regulatory guidelines on electronic submissions from FDA. This article discusses the urgency as well as the findings of a 2015 global commercial content management study. Each year, life sciences companies send more than 80,000 promotional material submissi...
  • Regulatory NewsRegulatory News

    Electronic Application Forms Mandatory for EU Centralized Procedure

    Beginning today, the European Medicines Agency (EMA) will require companies to use new electronic application forms (eAF) for all medicines applying to the centralized procedure. Background In March 2012, EMA piloted the use of electronic application forms as part of its efforts to modernize the marketing authorization process. Since then, EMA has allowed companies to submit their initial marketing authorization applications in either electronic or paper format. Then i...
  • Regulatory NewsRegulatory News

    EMA Holds Final Round of Testing Before New Electronic Forms are Required

    The European Medicines Agency (EMA) is conducting user-acceptance testing of new electronic application forms (eAF) in preparation for the transition to electronic-only applications on 1 July 2015. Background In February, EMA announced it would require all new human and veterinary medicines using the centralized procedure, including variations and renewals, to use eAFs as opposed to paper applications. EMA began using electronic application forms for marketing au...
  • 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

    Brazilian Device Industry Prepares for eSubmissions

    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. Brazil's medical device industry should prepare for electronic submissions, Anvisa, Brazil's national regulatory agency, said at a 20 August 2014 meeting . The meeting provided an opportunity for the agency to discuss its implementation strategy for the International ...
  • Regulatory NewsRegulatory News

    FDA's 'TurboTax' Pilot Program for Medical Devices Expanding

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is expanding a new pilot program that it hopes will make medical device submissions a lot less complicated and a lot more like filing taxes using TurboTax. Background As explained by FDA in May 2014, its new 510(k) eSubmissions Program will help guide companies through the construction and submission of a premarket notification [510(k)] application, "eliminating the need for a ...
  • Regulatory NewsRegulatory News

    India Proposes eSubmission Process for Clinical Trials

    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. India’s Central Drugs Standard Control Organization (CDSCO) has published a proposal to create an information technology (IT) system that would permit the online submission of information on clinical trials by sponsors, clinical research organizations (CROs), investigators, e...
  • 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...
  • New 510(k) Pilot Program Aims to Take the Frustration out of Submissions

    Each year in the US, millions of Americans choose to utilize the services of an online tax preparation service like TurboTax, H&R Block, TaxACT and others. The Internal Revenue Service (IRS) has also gotten into the business of making it easier to file with its own Free File Software , available to consumers making less than a certain income. Despite its cost, the software is popular because it makes filing taxes-ordinarily a time-consuming, confusing and otherwise ...
  • 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...