Search Results for common technical document

Showing 1 – 20

FDA Offers New ICH Guidance on Organizing a CTD By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA.

Categories: News, Canada, Europe, US, FDA, ICH, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: eCTD, common technical document, ICH guidance

Health Canada to go eCTD-only for Drug Applications By Michael Mezher - Published 25 April 2017

Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format.

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

Tags: Electronic Common Technical Document, eCTD

FDA Delays eCTD Requirements for Master Files By Michael Mezher - Published 07 April 2017

The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: drug master files, biological product file, DMF, BPF, electronic common technical document, eCTD

Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan By Satoshi Koike, PhD, DSc - Published 23 March 2017

This article focuses on key regulatory activities to establish a Joint Venture (JV) for pharmaceutical manufacturing and sales in Japan. The author describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities.

Categories: Features, Japan, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Common Technical Document, CTD

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

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

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

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 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

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

'Major Updates' to eCTD Module 1 Released by FDA By Alexander Gaffney - Published 03 August 2012

Categories: FDA

Tags: Module 1, Electronic Common Technical Document, Latest News, eCTD

Health Canada Finalizes eCTD Guidance By Alexander Gaffney - Published 25 June 2012

Categories: Health Canada

Tags: Electronic Common Technical Document, Submissions, CTD, DOssier, Latest News, pharmaceutical, eCTD, drug

Health Canada Looking to Transition all Submissions to eCTD Format By Alexander Gaffney - Published 27 April 2012

Categories: Health Canada

Tags: Electronic Common Technical Document, Submissions, CTD, DOssier, Latest News, pharmaceutical, eCTD, drug

Canada: New eCTD Guidance In Effect By Ansis Helmanis, RegLink - Published 02 April 2012

Categories: Regulatory Update, Canada

Tags: Pyramid, eCTDs, Module, common technical document, guidance