eCTD

The Regulatory Affairs (RA) profession has been gradually embracing electronic working for some years now. Whilst many of us both inside and outside the industry remain sceptical about the likelihood of ever achieving the 'paperless office' we have actually taken significant steps towards this goal over the last 10 years. The latest driver is the fully electronic Common Technical Document (eCTD) as defined by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the various regional authorities.

What is eCTD?

The phrase 'electronic Common Technical Document' suggests something simple and straightforward. Surely it's just the electronic version of the paper documents we prepare already?

Sadly this is not the case. The ICH eCTD specification is actually a long and complex document that contains some information that is useful to the RA professional but in fact is of most use to a software developer.

When asked what eCTD actually is we like to give two answers. There's a technical answer, that goes something like this;

"eCTD is an XML backbone with associated metadata and checksums, plus a predefined directory structure reflecting the XML nodes and leaves, containing properly granulated and formatted electronic documents".

This is the non-technical answer;

"eCTD is a sort of web page, and a whole set of documents and folders, split up in a particular way, that link together so that the agencies can process your submissions more quickly and easily".

In actual fact you can open an eCTD XML file in your browser and it looks just like a web page, with links to the documents contained within it; no additional software is required. However behind the scenes there's a hugely complicated, very precise structure that can be broken with a single misplaced full stop. It's really not the sort of thing you want to be trying to create without a specialist tool, hence all this talk about eCTD software. That's where Samarind RMS comes in with its integrated eCTD publishing tools.

  • Construct your eCTD from your product and submissions details, which are held within the SQL database;
  • Predefined eCTD structure is presented in a user-friendly format, allowing you to assign the correct regulatory document to the correct eCTD branch or leaf within the dossier, using a simple drag and drop technique;
  • Full eCTD sequence creation and generation is supported, with the ability to view all sequences incrementally or individually;
  • Document templates contained within the system provide fast, easy and consistent document creation;
  • Builds in relationships between sequences for initial submissions, variations, responses to RFIs etc.;
  • eCTD publishing into the correct defined file structure in readiness for writing to DVD.

Now in its third major version and spporting pharmaceutical manufacturers across 4 continents, Samarind RMS is a fit-for-purpose time efficient toolset, which not only allows you to create and submit your electronic dossiers in the correct eCTD format, but it also helps to cohesively manage the whole process of acquiring your licences/marketing authorisations and maintaining drug licence submissions.

Samarind RMS is equally suited to innovator and generics drug companies, and it is also ideal for use by pharmaceutical regulatory consultants.

For further information please contact us.