The file you submit and the way you answer queries affect the review. A practical look at what your team can prepare.
A review timeline depends on more than the authority's assessment. The file you submit and the way you answer queries also matter.
Where the time goes
A review can include assessment periods and pauses while the applicant responds to questions. An incomplete response can lead to another query or another turn in the queue.
That is why a series of small gaps can add up to a longer review. Fixing the source of a query is often more useful than replying quickly.
What you can prepare
Check the right requirements
Confirm how the product is classified before you build the file. Classification affects which requirements apply. A gap review before submission helps your team address questions about the requirements while there is still time to change the dossier.
Make the dossier consistent
The quality and clinical sections need to describe the same product. Cross-check the sections before filing so an assessor does not have to ask your team to reconcile them.
Answer the question asked
Reply to each query with the relevant evidence and a clear reference to the file. If the question needs clarification, address that directly. Reframing it without resolving the issue can leave it open.
What this means for your filing plan
Allow time for review and query responses as well as the submission itself. A pre-submission audit can help you identify gaps before the authority does. You control the preparation and the quality of your responses; the authority controls its review and decision.
What does this mean for your product?
Discuss the evidence, requirements and next steps that apply to your situation.
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