Drug Safety: REPORTING TIMELINES
For a person undergoing drug safety training, it is important to know the reporting timelines of various cases to the regulatory authority because it is the active form of surveillance to assess the benefit-risk ratio of particular drug.
A person undergoing drug safety training should be aware that there are two types of reporting: Expedited Reporting and Periodic Reporting.
Expedited Reporting: It is done for ICSRs. Binary assessment is followed here.
- Serious/Nonserious
- Expected/Unexpected
- Causality: Related/Unrelated
Various timelines are as follows:
- Serious: Fatal/Life-threatening – 7 calendar days from IRD/CSD
- Serious: Non-fatal/Non-life-threatening -15 calendar days from IRD
- Non-serious cases -90 calendar days from IRD
Periodic/Aggregate Reporting:
- Pre-approval aggregate reports – DSURs: Within 60 calendar days from the DSUR data lock-point
- Post-approval aggregate reports: PADERs- In USA: These include all serious unlisted cases– submitted once in a quarter for 3 years (within 30 days of close of quarter) and later annually within 60 days of US approval date until the drug is very well established in the market.
- PSURs- in Europe and other regions:
Reporting Interval | Type of medicinal product | Reporting Timeline |
6 months reporting | Newly-marketed and those for a year in the market | 70 calendar days |
Annual reporting | In market for more than one year | 90 calendar days |
Multilayer Reporting | In market for more than 5 years | 90 calendar days |
