eCTD submission Regulatory

Summary Related CEP 2.0

What is the CEP 2.0?

From the September 2023 this new CEP2.0 will be implemented. 

Manufacturer and the various organization want to know about what cep2.0 

Cep2.0 is new look or the future cep. 

1.What will change in the CEP2.0 

As part of the implementation of the CEP 2.0, some changes are introduced, which affect the requirements for the content of CEP applications for chemical purity and for Herbal Drugs/Herbal Drug preparations. 

The revised requirements apply to newly submitted applications for a new dossier, a sister file and a renewal. 

  1. Requirements for the content of the CEP dossier

The Some of main changes are as follows. 

General properties  

For active compounds, CEP holders/applicants should include the Maximum Daily Dose (MDD), route of administration, and duration of treatment used for the creation of their control strategy and specification presented in section 3.2.S.1.3 of the CEP dossier. This information should be based on Human medicine (EPAR), (SmPCs), or agreed literature such as Martindale. 

Description of manufacturing process and Process Controls (3.2.S.2.2):  

The process description should contain only information that corresponds to quality/grade claimed.  

Details on steps such as micronisation or sterilisation, preferable not include if the corresponding grade is not requested.  

 Control of materials 

The quality of the water used within the manufacturing process shall be in line with the EMA “Guideline on the quality of water for pharmaceutical use. 

The quality of the water used in the last manufacturing steps (as a solvent or during isolation and/or purification) will be reported on the CEP when granted.  

 Specification (3.2.S.4.1) 

The specification for the substance needs to preferably not include exams implemented to comply with other pharmacopoeias than the Ph. Eur. (e.g., USP).  

It needs to be provided in tabular layout. Parameters, limits, and reference suggested within the table (e.g., Ph. Eur., in-house). In case of in-house impurities control inside the substance, an unequivocal chemical name of the compound should be used (in-house code can be added if relevant). The given text ought to be legible (e.g., freed from highlighting, tracked modifications, coloured textual content, and watermarks) and the use of scanned files is to be averted.  

similarly, the specification of the substance must comprise simplest records corresponding to the quality claimed (specification for particle size, microbiological controls, and many others. must not be included in the file if no corresponding specific grade is asked). 

 An example of specification is stated as Annex 1 on the EDQM website 

 Analytical procedures (3.2.S.4.2):  

To facilitate the preparation of CEP. CEP holders/Applicants required to divide the analytical test Procedure for their substance into two distinct subsections and to submit “clean” documents. 

Subsection 1 – Alternative in house analytical test procedures to those of the Ph. Eur. monograph  

Subsection 2 – Additional in-house analytical test procedure(s)  

An example for present the additional in-house analytical test procedure is stated as Annex 2 on the EDQM website. 

 How to implement this in the e-submissions  

As per the requirements CEP holders/applicants need to submit 3.2.S.4.2 In two section as follows. 


32-body data  



                                               analytical procedures-equiv_ih-subsection 1  

                                               analytical procedures-add_ih-subsection  

For more details, 



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