Need for action
What’s new?
More and more countries now demand the electronic submission of dossiers in the form of eCTDs; this format is already mandatory for the centralised marketing authorisation procedure.
A suitable document management and publishing system is a prerequisite for the effective creation of eCTDs. This applies to the compilation of original dossiers, as well as to the ongoing documentation of the marketing authorisation process over a longer period (lifecycle management).
Others are only just beginning – we have already acquired years of experience with eCTDs.
YES launched such a system in 2004. Building on our extensive work in this area, we have continuously improved our activities and processes.
Via to our continuous contacts with the regulatory authorities and software developers, we are always aware of any planned modifications to the electronic specifications. In addition, our broad international customer base gives us a good insight into the state of e-submission compliance in the individual companies.
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The introduction and deployment of eCTD systems will necessitate the analysis and modification of your in-house workflow, plus an entirely new approach to lifecycle management.
For a rational input of time and resources it is essential to realise that the introduction of eCTDs is more than just a technical challenge.
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Facts
As from January 2010 the eCTD format will be mandatory for all electronic submissions relating to the centralised marketing authorisation procedure. Likewise with effect from January 2010, electronic-only submissions will be permissible – or demanded – in a further 20 European countries. For veterinary medicinal products, electronic applications are required in individual countries since 2011.
For a number of years now the "electronic Common Technical Document" (eCTD) has been the internationally recognised standard for paperless regulatory submissions for medicinal products. To ensure the rapid validation and processing of applications it is essential to comply exactly with the extensive specifications formulated at an ICH and EU level.
Structural and logistical know-how plays a pivotal role – alongside suitable programmes for the compilation and updating of dossiers throughout the product lifecycle (variations, renewals, extensions).
Strategy
eCTD is a strategic task. No pharmaceutical company can afford to ignore eCTD if it wants to operate successfully in world markets.
There are various options for the deployment of eCTDs. The correct approach will depend on various factors ( e.g. the size of your company, target markets, market requirements, etc.).
The essentials for a sustainable strategy are as follows:
- a clear analysis of the "as is" situation;
- a decision in favour of internal eCTD implementation or (temporary) outsourcing;
- adaptation of in-house processes to the chosen strategy;
- selection and implementation of the optimum in-house publishing tool, including the necessary staff training;
- selection of a suitable outsourcing partner that can draw on extensive previous experience.
In most cases it will be necessary to adapt your internal processes in order to achieve maximum effectiveness.
Our checklist will enable you to gauge you degree of preparedness.
Our services
If you are inclined/required to make submissions in eCTD format, we can assist you in a variety of different ways.
- This can begin with an extensive analysis of your processes and requirements,
- and continue with the implementation of the necessary processes and tools, accompanied by staff training.
- We can also offer you effective operational assistance with your initial eCTD submissions.
We deploy the same processes to create eCTDs and CTDs (for veterinary medicinal products in NtA format, too). This simplifies the future transition from paper-based dossiers to their electronic equivalents.
If you decide not to introduce eCTD in your company (for the time being at least), you can nonetheless depend on our eCTD expertise:
- We will create and update your dossiers in line with your requirements, and
- ensure that your marketing authorisations are properly maintained.
If, at a later date, you decide to introduce eCTD and resume responsibility for dossier management tasks, we can help you to port your marketing authorisations to the new system.
Checklist
