Anavex Life Sciences Corp (AVXL)

[Investor2014]

The CHMP expects to have all information filed with the MAA, not being drip fed during the evaluation period.

New information only in defined windows and formats. During an ongoing MAA review the CHMP will consider new information when it is submitted as part of responses to the Day-120 List of Questions (Clock-stop 1) or to the Day-180 List of Outstanding Issues (Clock-stop 2). Outside those windows, unsolicited “extra data” is generally not taken on board. After CHMP adopts an opinion, no new evidence can be added during a re-examination. Post-authorisation, EMA can require further studies (PASS/PAES).

EMA’s “Evaluation of medicines, step-by-step” page spells out the LoQ -> Clock-stop 1, LoOI -> Clock-stop 2 framework, RMP updates during stops, and the no-new-evidence rule at re-examination. ([European Medicines Agency (EMA)][1])

Bottom line: CHMP will review new or updated evidence only when it is properly submitted as part of your LoQ/LoOI response packages. You can’t continuously add data outside those steps, and once an opinion is adopted, the re-examination cannot include new evidence. (European Medicines Agency (EMA)[2])

[1]: The evaluation of medicines, step-by-step | European Medicines Agency (EMA)
[2]: Improving efficiency of approval process for new medicines in ...