eCTD submissions for generics

In the last two years there was a substantial development in the use of electronic registration applications (first of all eCTD).

This was due on one hand to the requirements of the authorities (in several countries as Austria, Czech Republic, Germany, Hungary, Ireland, Norway, Sweden, UK definitely preferred) on the other hand many smaller companies started to use eCTD.

There are well-known advantages of eCTD over the paper and Nees (Non-eCTD electronic Submission) documentations:

For the pharma companies it facilitates:

-         the easy and standard compilation of registration files

-         producing country specific versions

-         life cycle management

-         well controlled changing or modifying documents

-         creating links to other documents

For the registration authorities it accelerates:

-         the review and evaluation of submissions

-         the evaluation of the documentations offering simultaneous access for the individual departments and experts

-         compiling assessment reports faster and easier

For everyone it helps the effective and exact archivation of all the registration documents. 

When analyzing the possible reasons why in the last two years there was a great change in the use of eCTD we can see that earlier it was mostly preferred by multinationals but nowadays more and more small and medium size companies realize that eCTD is an excellent tool for compiling and handling generic files. Specialized small consultancies prepare multi-purpose generic files for marketing firms. (Special role of eCTD in the development and registration of generics, T. Szuts, Hamburg 10-12 June 2008)

 

In the near future we shall publish a detailed list of acceptance in all the EU-countries.