Expedited Reporting

An individual case safety report of one or more adverse events that must be submitted within a specified amount of time due to the severity of events, is Expedited reporting

Worldwide regulatory authorities require expedited reporting of individual cases received by drug companies that meet specific criteria like validity, seriousness, expectedness of events and relation between medication and event.

The purpose of expedited reporting is to make regulators, investigators, and other appropriate people aware of new, important information on serious reactions. 

Therefore, such reporting will generally involve events previously unobserved or undocumented, and a guideline is needed on how to define an event as “unexpected” or “expected’’.

Standards for Expedited Reporting – Clinical Trial cases – What cases to be reported?

• Single Cases of Serious, Unexpected ADRs 
• For an “expected,” serious ADR, an increase in the rate of occurrence which is judged to be clinically important. 
• A significant hazard to the patient population, such as lack of efficacy with a medicinal product used in treating life-threatening disease. 
• A major safety finding from a newly completed animal study (such as carcinogenicity).
  

Expedited Reporting time frames – Clinical Trial cases

1. Death/Life threatening cases and SUSAR (Suspected Unexpected Serious Adverse Reaction) cases are reported within 7 calendar days to the HA (health authorities). 
2. Clinical trial other Serious unexpected cases and safety issues are reported in 15 calendar days timeframe. 
3. Post – study event information is not routinely collected by the sponsor, serious adverse events that occurred after the patient had completed a clinical study (including any protocol- required post-treatment follow-up) will possibly be reported by an investigator to the sponsor. Such cases should be regarded for expedited reporting purposes as though they were study reports.
   

Standards for Expedited Reporting – post market products – What cases to be reported?

• Individual serious unexpected adverse drug reaction reports originating from foreign regulatory authorities are subject to expedited reporting to other authorities by each MAH. 
• Cases of adverse drug reactions that are both serious and unexpected are subject to expedited reporting. 
• The reporting of serious expected reactions in an expedited manner varies among countries. 
• Non-serious adverse reactions, whether expected or not, would normally not be subject to expedited reporting. 
• In addition to single case reports, any safety information from other observations that could change the risk-benefit evaluation for the product should be communicated as soon as possible to the regulatory authorities in accordance with local regulation. 
• Evidence of lack of efficacy should not normally be expedited, but should be discussed in the relevant periodic safety update report. However, in certain circumstances and in some regions, individual reports of lack of efficacy are considered subject to expedited reporting. 
• Reports of overdose with no associated adverse outcome should not be reported as adverse reactions. Cases associated with serious adverse reactions are considered subject to expedited reporting, unless otherwise specified by local regulation. 

Expedited Reporting time frames – Post marketing cases

• Expedited reporting of serious and unexpected ADRs is required as soon as possible, but in no case later than 15 calendar days of initial receipt of the information by the MAH. Time frames for other types of serious reports vary among countries, depending on source, expectedness and outcome. 
• Cases of non-serious ADRs, whether expected or not, would not normally be considered reportable on an expedited basis. Non-serious ADRs should be included in the periodic safety update report 

References:

• ICH E2A CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
• ICH E2D Post-approval safety data management
• CIOMS 1