Answer:

Only methods that supplement those described in the relevant Ph. Eur. texts that are needed to control the quality of the substance will be appended to the CEP 2.0. Alternative in-house methods that have been demonstrated as being equivalent to those described in the Ph. Eur. will not be appended to the CEP 2.0.

To facilitate the preparation of CEPs, holders and applicants are expected to divide section 3.2.S.4.2 analytical procedures for their substance into two distinct subsections and to provide “clean” documents:

• subsection 1 - Alternative in-house analytical procedures to those of the Ph. Eur. monograph;
• subsection 2 – Additional in-house analytical test procedure(s).

How to implement this for new dossier applications

In order to address the abovementioned requirements, CEP applicants are requested to separate section 3.2.S.4.2 into two distinct sections as follows:

m3

32-body data

32s-drug-sub

32s42-analy-proc

analytical procedures-equiv_ih-subsection 1

analytical procedures-add_ih-subsection 2

How to implement this for renewal or revision applications

If section S.4.2 is currently one document, there are two options:

• Option 1: the CEP holder continues to have this document as one document but reorganises the content as described above.
• Option 2: the CEP holder decides to split the document into two and use the “replace” action for one of the subsections and the “new” action for the second subsection in the e-CTD*. Please note, that it is advised not to use the “delete” action in the e-CTD

(*eCTD or VNeeS for substances for veterinary use only)