I'm reading a WHO guidance, and I am not sure what it means:
188.8.131.52 General considerations 20
Comparative safety data should normally be collected pre-authorization. The extent of collection 21 depends on the type and severity of safety issues known for the reference product. The SBP study 22 population should be followed to provide information on safety events of interest according to the 23 experiences with the reference mAb. Care should be given to compare the nature, severity and 24 frequency of the adverse events between the mAb SBP and the reference product in clinical trials 25 that enrolled a sufficient number of patients treated for an acceptable period of time. Clinical 26 safety issues should be captured throughout clinical development during initial PK and/or PD 27 evaluations and also in the primary clinical study establishing comparability.WHO Guideline
Here, what does "should be collected pre-authorization" mean?
Please help me.