How to file eCTD in MRP/DCP - One decision already made?

When filing a new eCTD using the Mutual Recognition or Decentralised Procedure, you need to be aware of the following question:

“When an application refers to multiple strengths or dosage forms, should I create one eCTD covering ALL strengths and dosage forms, or should I create one eCTD for EACH?”

This is no concern under the centralised procedure, where one eCTD will be submitted to cover all dosage forms and strengths: i.e. there’s no room for discretion.The advantages and disadvantages of both approaches are discussed in the TIGes guidance, but can be summarised as follows:

One eCTD for all forms/strengths:

Advantages
-                Common documentation, including Clinical, Nonclinical and some Quality data is provided only once.
-                Only one eCTD needs to be published (less publishing required, easier to control…etc.).

Disadvantages
-          The overall application will contain a greater number of sequences than if the eCTD is split (i.e. one sequence added per change to each and any of the forms/strengths).
-          Where some countries apply only for certain strengths, it can become confusing when tracking which countries are involved in any individual lifecycle.

One eCTD per form/strength

Advantages
-          Fewer sequences per eCTD application.
-          No confusion about which countries are involved in any individual application update.

Disadvantages
-          Common data is duplicated across different applications
-          More overall eCTD lifecycles to create and maintain (more publishing time required)

 However, following a recent publication by the Slovakian NCA (kindly Tweeted by Exalon), it’s clear that the discretionary nature of the above methods of application isn’t quite as clear cut as it may seem:

              “for each registration number in Slovakia (for each strength, each pharmaceutical form), or procedural number (MRP, DCP) to which the application relates [it] is necessary to create a separate directory…”    [emphasis my own]

Clearly there is a need either:

-          For the approved TIGes guidance to be updated, or
-          For all NCAs to understand that either filing approach is allowable.

If you’d like to know more about eCTD, please feel free to contact us via our website: www.apexregulatory.co.uk; our number’s at the top of the page, or use our Contact Form.
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