Baseline documentation – Variations – Versions

As it can be seen on our first February table (Paper, electronic non - eCTD and eCTD acceptance in the EEA) eCTD is going ahead full speed and becames obligatory in many countries.

On this basis a very ridiculous situation emerges that you must submit variations in eCTD format (version) without having a basic eCTD documentation.

By the definition of eCTD this is impossible but some authorities still require (we had it in our practice) as if building a new roof on top of a non-exiting house.

The “Guidance for  Industry  on  Providing  Regulatory Information in Electronic Format: eCTD electronic Submissions V 1.0,  May 2009” suggest (not obligatory) a solution to prepare a baseline documentation in eCTD format or a special shortened form:

„However, in relation to the first variation in eCTD format, the applicant is strongly encouraged to also submit a so called “baseline eCTD”, i.e. to submit the current dossier in an eCTD format, at least Module 1, the cover letter and product information as a minimum, and Module 3. This ”baseline eCTD” would then be submitted as sequence 0000 and the first variation in eCTD format submitted as sequence 0001.„

Considering that according to our estimation tens of thousands of registration documents were approved in the past ten years in the EEA this seems to be a very substantial work. (We are glad to prepare baseline eCTD documents for our partners!)