• 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...
  • US Health IT Officials Call for Integration of FDA's Unique Device Identification with eHealth Records

    The Office of the National Coordinator (ONC), a US health technology implementation advocate, has announced a new proposed rule that would advocate for the integration of the US Food and Drug Administration's (FDA) recent Unique Device Identification (UDI) rule with electronic health records (EHRs). Background A  UDI  is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulator...
  • 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 ...
  • Guidance: Everything You Ever Wanted to Know About Receipt Dates for Electronic Submissions

    US regulators have released yet another guidance document on electronic submissions-the US Food and Drug Administration's (FDA) third in the span of a week-this time on receipt dates for drug applications submitted electronically. 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 505(b)/(i)/(j) or 351(a)/(k)-that is, any...
  • What's Holding up FDA's Electronic Drug Labeling Rule?

    Legislators with the two committees that oversee the US Food and Drug Administration (FDA) want to know: What's holding up the agency's electronic labeling rule for pharmaceuticals? Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce uniformity were first passed. Those measures were substantially updated in 2006 under FDA's Requirements on Content and Format of Labeling for Human Prescript...
  • FDA's New Roadmap for Electronic Format Submission Offers Vision but Few Details

    New draft guidance released this week by the US Food and Drug Administration (FDA) aims to explain a roadmap for how pharmaceutical and biopharmaceutical manufacturers will eventually need to submit marketing applications electronically as required by federal law. 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 505(b)/(i)/(...
  • FDA Issues Change to Make it Easier to Submit Citizen Petitions

    It's about to become a lot easier to submit Citizen Petitions to the US Food and Drug Administration (FDA), the agency has announced. The petitions are essentially formal requests made to FDA to take an action-approve a product, declare that a product was not withdrawn from the market for safety reasons, institute a new policy, or even refrain from approving a generic drug product based on potential problems. The wide range of potential uses for the petitions makes them...
  • Updated Electronic Submission Guidance for Device Manufacturers Reflects FDA's 'Experience to Date'

    US medical device regulators have released a newly updated guidance document on the submission of electronic copies of device submissions under a program known as "eCopy," expanding the guidance by several pages to include "clarifications" based on the agency's "experience to date with the program." The eCopy program was brought into law under Section 745A9b) of the Food and Drug Administration Safety and Innovation Act (FDASIA) . As explained by FDA, "An electronic co...
  • 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...
  • MHRA Advocates Use of Online Submissions Platform by Applicants

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is "strongly" encouraging all applicants to participate in its pilot participation in the Central European Submissions Platform (CESP), an online-based secure submissions system. Currently, applicants are permitted to submit applications to MHRA using data contained on CDs or DVDs, depending on the size of the submission. However, this submission style necessitates manual handing of media, storage spac...
  • FDA Releases Guidance Document on Soon-To-Be-Mandatory Device Submission Program

    The US Food and Drug Administration (FDA) has released a new draft guidance document on a new digital medical device submission system. The system, known as the eCopy Program, is soon to be required of certain manufacturers under the terms of the recently passed FDA Safety and Innovation Act (FDASIA) , Section 745A(b). As explained by FDA, "An electronic copy (eCopy) is defined as an exact duplicate of the paper submission, created and submitted on a CD, DVD, ...
  • Australia to Launch Consultation on Development of eCTD Guidelines, Timetable

    Australia's Therapeutic Goods Administration (TGA) is preparing to establish procedures, guidelines and a timetable for the implementation of the submission of medicine applications using the electronic Common Technical Document (eCTD), it announced on 9 October. The eCTD is an electronic, module-based regulatory application format developed and maintained by the International Conference on Harmonisation (ICH). The basic premise of the eCTD is to harmonize the layout a...