Search Results for CTD

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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

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

South Africa Medicines Regulatory System Overview By Elias Nyberg and Emma Burr Nyberg - Published 30 January 2015

South Africa’s pharmaceutical regulating body, the Medicines Control Council (MCC), is staffed to review a dossier completely to international standards, and it conducts its own review of the complete dossier, regardless of other major regulatory approvals. In the last decade, limited resources have meant increased review timelines. To ensure a timely and successful application, it is crucial for pharmaceutical companies to facilitate open discussions and exchange information with key MCC regulators, listed herein.

Categories: Features, Africa, Drugs, Government affairs, Submission and registration

Tags: South Africa, Medicines Control Council, responsible pharmacist, harmonization initiative, CTD, dossier

Australia’s TGA Issues Amended Nonclinical Studies Guidance By Louise Zornoza, RegLink News - Published 17 September 2014

Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued an amended guidance on nonclinical studies for Module 4 of the Common Technical Document (CTD), which is an integral part of an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG). 

Categories: News, Oceania, TGA, Preclinical

Tags: ARTG, TGA, Australia, Module 4, CTD

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

In Landmark Vote, EU Passes New Clinical Trial Regulation, Including Data Transparency Measures By Alexander Gaffney, RAC - Published 02 April 2014

Tags: Clinical Trial Transparency, 2001/20/EC, European Parliament, CTD, Clinical Trials Directive, Transparency, Latest News, clinical trials, EU

EU Overhaul of Clinical Trials Directive Advances, Would Demand Full Data Transparency By Alexander Gaffney, RF News Editor - Published 30 May 2013

Tags: European Parliament, EP, CTD, EU

FDA Signs onto ICH Guidance on E3 Guideline By Alexander Gaffney, RF News Editor - Published 29 January 2013

Categories: FDA, ICH

Tags: E3, CTD, eCTD, guidance

FDA Announces Adoption of ICH's Q11 Manufacturing Guideline By Alexander Gaffney, RF News Editor - Published 19 November 2012

Categories: FDA, ICH, Manufacturing

Tags: Q11, CTD, eCTD, development

Industry Pledges Tentative Support for Clinical Trials Data Transparency By Alexander Gaffney, RF News Editor - Published 14 November 2012

Tags: Clinical Data, EFPIA, CTD, Transparency, Latest News, data, clinical trials

Incoming EU Health Commissioner Lays out Plan for Pharma, Medical Device Sectors By Alexander Gaffney, RF News Editor - Published 09 November 2012

Tags: Health Commission, Tonio Borg, CTD, Clinical Trials Directive, Latest News, pharmaceutical, drug, EU, medical device

New EU Clinical Trials Proposal to Ease Pharmaceutical Industry's Concerns By Alexander Gaffney - Published 18 July 2012

Categories: Europe, EC

Tags: Revision, CTD, Clinical Trials Directive, Legislation, European Commission, Latest News, clinical trials, EU

Breaking: European Commission Adopts Proposal for a 'Clinical Trials Regulation' By Louise Zornoza, RegLink - Published 17 July 2012

Categories: EMA

Tags: CTD, Clinical Trials Directive, Latest News, regulation, clinical trials

Voluntary Harmonization Process for Multinational Clinical Trials in the EU By Surendra Gokhale, PhD and Marina Gasser-Stracca, PhD - Published 29 June 2012

In April 2001, Directive 2001/20/EC (the Clinical Trials Directive) came into force with the objective of harmonizing clinical trial processes and detailing the legal provisions for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) across the EU. The aim was to increase and standardize the protection afforded to clinical trial participants. This article discusses the CTD and harmonization efforts at work in Europe.

Categories: Features, EMA

Tags: CTD, Clinical Trials Directive, harmonization, clinical trial, EU

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

Electronic Submission Gateway Goes Live for Human Medicines Submissions, Announces EMA By Alexander Gaffney - Published 23 April 2012

Categories: EMA

Tags: eSubmission Gateway, Centralized Procedure, CTD, Centralised Procedure, electronic, Latest News, eCTD, submission, MAH

EMA Launches Pilot Program for Electronic Applications By Alexander Gaffney - Published 12 March 2012

Categories: EMA

Tags: CTD, Pilot, Pharmaceuticals, electronic, Latest News, eCTD, program, submission