Search Results for eCTD

Showing 1 – 25  of 44

May Deadline for FDA's eCTD Transition Approaches By Zachary Brousseau - Published 13 February 2017

Beginning 5 May, pharmaceutical, biologic and generic manufacturers will have to submit to FDA all New Drug Applications, Biologics License Application and Abbreviated New Drug Applications using the electronic Common Technical Document (eCTD).

Categories: HTML, Articles, Under RAPS, RAPS, Compliance, Generic drugs, Prescription drugs, Submission and registration

Tags: eCTD, electronic Common Technical Document, Submissions

Strategies for Smarter Compliance in a Technology-Driven FDA Environment By Matthew M. Lowe - Published 26 January 2017

The article provides an overview of the significance of technology in the regulatory compliance process and offers strategies for smarter compliance.

Categories: Features, US, FDA, Biologics and biotechnology, Drugs, Medical Devices, Submission and registration

Tags: eCTD, Electronic Common Technical Document

FDA Offers Technical Rejection Criteria for Study Data By Zachary Brennan - Published 11 November 2016

For clinical and nonclinical studies starting after 17 December 2016, the US Food and Drug Administration (FDA) is requiring the use of data standards listed in the FDA Data Standards Catalog for all new drug applications (NDAs), biologic license applications (BLAs) and abbreviated new drug applications (ANDAs).

Categories: News, US, FDA, Advertising and Promotion, Biologics and biotechnology, Clinical, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: eCTD, study data files submitted to FDA

China Food and Drug Administration Issues New Requirements for Clinical Trial Applications and New Drug Applications By Gretchen Dean, MA, Joel Hardink, MBA, MS - Published 17 October 2016

This article discusses the growth of China's pharmaceutical market, background of the global use and acceptance of the Common Technical Document (CTD), outlines the China Food and Drug Administration (CDFA) requirements for Clinical Trial Application (CTA) approval and New Drug Application (NDA) registration as critical steps in addressing drug quality, patient safety and shortening the time for access to new drugs.

Categories: News, China, CFDA, ICH, Clinical, Drugs, Submission and registration

Tags: Electronic common technical document, eCTD, Clinical trial application, CTA,

Regulatory Focus Features Recap: July 2016 By Gloria Hall - Published 29 July 2016

Feature articles for July focused on managing regulatory information and systems and eCTD submissions.

Categories: Features, Submission and registration

Tags: Features Recap, Regulatory Focus, eCTD, Electronic Common Technical Document

eCTD: Journey Through the Decade By Pallavi Trivedi, Sharad Trivedi - Published 21 July 2016

This article discusses transitioning and implementing the electronic Common Technical Document (eCTD) in different regions a decade after its conceptualization. The article further discusses its impact on dossier compilation and document design practices as well as challenges faced by the pharmaceutical industry for effective lifecycle management.

Categories: News, Japan, Canada, Europe, US, Submission and registration

Tags: Electronic Common Technical Document, eCTD

Accelerating Global Submissions with a Six-Point eCTD Strategy By Steven Dowdley, Chet Shemanski - Published 05 July 2016

This article discusses how an integrated, six-point electronic Common Technical Document (eCTD) publishing strategy can accelerate global submissions and enhance the efficiency of regulatory operations. In addition, it outlines challenges specific to: large companies with a well-established, eCTD-compliant publishing capacity, but may lack strategic agility; and smaller companies with limited eCTD resources and expertise.

Categories: Features, Japan, Canada, Europe, US, FDA, Drugs, Regulatory strategy, Submission and registration

Tags: eCTD, Electronic Submissions, Common Technical Document

FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics By Zachary Brennan - Published 22 June 2016

The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: ISCRs, ICH, eCTD, E2B(R3)

Streamlining the Regulatory Review Process in Pharma: The Upcoming Transition to Electronic Common Technical Documents Published 13 January 2016

For pharmaceutical companies, filing Common Technical Documents (CTDs) is a critical aspect to the regulatory approval process. Historically, this process has been paper-centric until recently. This exclusive interview features a recent collaborative effort between West Pharmaceutical Services, FDA, Health Canada and others to establish a process and protocol for filing CTDs electronically, which will likely become common practice as early as 2017.

Categories: News, Canada, US, FDA, Health Canada, Drugs, Submission and registration

Tags: eCTD, Electronic Common Technical Document

FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years By Alexander Gaffney, RAC - Published 07 May 2015

Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: eCTD, Electronic Common Technical Document, NDA, BLA, IND, 505(b)(2), DMF, BPF

Going Digital: EMA to Ditch Paper, Require Electronic Application Forms By Michael Mezher - Published 26 February 2015

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.

Categories: News, Europe, EC, EMA, ISO, Drugs, Regulatory strategy, Submission and registration

Tags: eCTD, CTD, electronic application forms, eAFs, eSubmissions Roadmap, ISO IDMP

ICH Takes Step Toward New eCTD Version By Michael Mezher - Published 24 February 2015

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).

Categories: News, Japan, Europe, US, EMA, FDA, ICH, PMDA, Submission and registration

Tags: ICH, International Conference on Harmonization, eCTD, electronic submissions

Writing Regulatory Documents with E-Submissions in Mind By Leslie E. Stolz, PhD, and Michael A. Frantz - Published 22 January 2015

Preparing regulatory documents for electronic submission (known as publishing) can be time consuming and complicated. This article offers some practical tips to help authors prepare regulatory documents in a more efficient manner, which can shorten submission timelines and save resources.

Categories: Features, Medical writing, Project management, Submission and registration

Tags: electronic submissions, cross-referencing, hyperlinks, eCTD, templates, style guides, leaf titles

FDA Releases New Electronic Submission Requirements for Biological Products By Alexander Gaffney, RAC - Published 02 September 2014

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.

Categories: News, US, CBER, Biologics and biotechnology, Submission and registration

Tags: LDR, LDD, Lot Distribution Reports, ESG, SPL, Structured Product Labeling, Electronic Submission Gateway, eCTD

FDA Issues Revised Guidance on Electronic Drug Submissions By Alexander Gaffney, RAC - Published 29 July 2014

The US Food and Drug Administration (FDA) has released a revised draft guidance document which instructs sponsors of pharmaceutical products on how to submit new product and trial applications using the electronic common technical document (eCTD) format.

Categories: News, US, CBER, CDER, Biologics and biotechnology, Drugs, In vitro diagnostics, Labeling, Submission and registration

Tags: eCTD, Guidance, Draft Guidance

FDA Looks to Improve Generic Drug Submission Quality in New Guidance By Alexander Gaffney, RAC - Published 11 June 2014

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).

Categories: News, US, CDER, Generic drugs, Medical writing, Submission and registration

Tags: eCTD, CTD, Common Technical Document, Electronic Common Technical Document, Guidance, Draft Guidance, Module, ANDA

FDA Releases New Study Format Validation Rules By Alexander Gaffney, RAC - Published 19 May 2014

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.

Categories: News, US, FDA, ICH, Clinical, Submission and registration

Tags: SEND, eCTD, Study Data, Clinical Data, Clinical Trials, Validation Rules

FDA Adopts Four Changes to the eCTD Application By Alexander Gaffney, RAC - Published 14 May 2014

Categories: US, FDA

Tags: eCTD Backbone, XML, Electronic Common Technical Document, Latest News, eCTD

PhRMA, BIO Express Unanimous Concerns About FDA Electronic Submission Guidance Docs By Alexander Gaffney, RAC - Published 13 May 2014

Categories: US, FDA

Tags: Electronic Submissions, BIO, PhRMA, Latest News, eCTD, guidance

Australian Regulators Launch Electronic Submission System for Pharmaceuticals By Alexander Gaffney, RAC - Published 26 February 2014

Categories: TGA

Tags: Electronic Common Technical Document, eCTD, australia

FDA Unveils New Changes to eCTD Submission Formats By Alexander Gaffney, RAC - Published 14 February 2014

Categories: US, FDA

Tags: Pharmaceutical Marketing, Electronic Common Technical Document, Latest News, eCTD

eCTD Revisions Published by FDA, Set for June 2014 Adoption By Alexander Gaffney, RF News Editor - Published 26 August 2013

Categories: US, FDA

Tags: Module 1, XML, Latest News, eCTD, update

EMA to Phase out Support for Non-Electronic Submissions in 2014 By Alexander Gaffney, RF News Editor - Published 23 May 2013

Categories: EMA

Tags: eSubmission, Centralized Procedure, Centralised Procedure, MAA, Latest News, eCTD

New FDA Policy Updates, Clarifies Process of Moving to Electronic Submission Forms By Alexander Gaffney, RF News Editor - Published 22 May 2013

Categories: US, FDA

Tags: MAPP, eCTD

eCTD Update Provides Guidance on Use of Image Media in Application By Alexander Gaffney, RF News Editor - Published 16 April 2013

Tags: XML, eCTD