CRED Getting the CMC Dossier Right 2024

Scenario: You work in a Regulatory Affairs consultancy team and have been asked by Drug Development company to advise on the information they need with the view of preparing a submission for a CEP.

They have provided you with the following documents:

Ph.Eur for Flurbiprofen

•

• Specification and some basic information • 6 months stability data • CEP guidance

You also have available an approved version of the monograph from the European Pharmacopoeia. You need to decide whether you have everything you need and if the information they have provided is complete and useable. Select a chairperson for your meeting. This will be the person who reports back to the Head of Drug Development with your group’s decisions so s hould be the one to take notes on the meeting.

Consider the following: Do you have enough information? If not, what else will you need to compile 3.2.S of the CTD? Is the information you have been given complete and accurate? If not, what remedial steps will need to be taken before you can compile and submit this part of the dossier?

Tips: Time is very limited so look for the most obvious omissions first. Once you have found these, go on to list the major problems (i.e. those that will result in the dossier being rejected at validation). After these have been discussed, and if there is enough time, look to see if you can avoid deficiencies during assessment. The chairperson should list all the points you find on the flip chart provided.