The Common Technical Document (CTD) replaced the Notice to Applicants (NtA) for the submission of licence applications, becoming mandatory in Europe in 2006. In 2005 the CTD format was adopted by the US and in 2008 there was a requirement for Japan to introduce this change, with a move in 2007/2008 for the rest of the world.

This followed review by the International Conference for Harmonisation (ICH) to produce one document acceptable by the Food and Drugs Administration (FDA) in the USA, the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Since January 2010 it is now mandatory for all submissions to be made in electronic CTD or eCTD format.

The CTD format is more structured, organised, and specified so that individual sections are more self-explanatory. The framework consists of five modules, four of which form part of the CTD as follows:

CTD Framework

Module 1 – This is not part of the CTD and is not defined by the ICH guidelines. It contains specific regional administrative information such as application forms.

Module 2 – This section introduces the pharmaceutical drug and includes key summaries of the submission data including, for example, the quality overall summary, non-clinical overview, and clinical overview.

Module 3 – This module contains the quality information for the drug substance, drug product and any relevant regional information. Module 3 is also referred to as the Chemistry, Manufacturing and Controls (CMC) section.

Module 4 – This section contains safety information presented in non-clinical study reports.

Module 5 – This contains efficacy information presented in the clinical study reports.

For older NtA dossiers any changes to the registered details must be filed in eCTD format to the relevant, often national, regulatory authority as they are still subject to regulatory controls for maintenance under change control.

Companies can manage this by converting the relevant sections of the NtA to eCTD format, or by converting the whole dossier. Whilst converting dossiers from NtA to CTD format, companies often assess the quality and relevance of the registered information and to ensure alignment and avoidance of registration drift.

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How Woodley BioReg can help with NTA to CTD

Woodley BioReg supports clients in NtA to CTD dossier conversion; this can be an onerous and resource-consuming task, so WBR provides flexible remote resourcing solutions  allowing clients to access resources as and when they need it.

Our high-speed scanners and OCR provisions minimises the potential for human and transcription errors whilst enabling updates as needed to ensure an up-to-date file.

Woodley BioReg works closely with a range of eCTD software providers and has developed robust and efficient methods to support “mass dossier conversions” from NtA (and other formats) to eCTD.

Our process involves extraction from often poor-quality photocopies or PDFs of NtA dossiers, and conversion to high quality eCTD submission-ready components. To add value during the conversion process, WBR can evaluate and remediate registration drift through conformance assessments against plant, manufacturing, testing, and release procedures as well as compliance against cGMP .