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  • 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

    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

    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...
  • 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...
  • 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...
  • 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...
  • EMA Expands Access to Electronic Submission Gateway Pilot to Include Veterinary Products

    The European Medicines Agency (EMA) announced 25 April it will expand access to its electronic submission gateway pilot program to include veterinary medicines. The program, dubbed the eSubmission Gateway, is an "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA. EMA had recently expanded the program, which was launched as a pilot program in January 2012, to include all human medicines after is saw "an increase in the spe...
  • Electronic Submission Gateway Goes Live for Human Medicines Submissions, Announces EMA

    The European Medicines Agency (EMA) is announcing its eSubmission Gateway-the "electronic submission channel" for submitting electronic common technical documents (eCTDs) to EMA-is now up and running for all applicants for centralized marketing authorizations. The program, announced 23 April, was originally launched as a pilot program in January 2012 meant to gauge the usefulness of the electronic submission process. EMA said in a statement it has seen "an increase in ...