What are the timelines for reporting adverse events?

What are the timelines for reporting adverse events?

The timelines for reporting adverse events can vary depending on the regulatory authority. For example, in the U.S., serious adverse events must be reported within 15 days.

Are there different timelines for different types of events?

Yes, there are different timelines. For instance, non-serious adverse events may have a longer reporting period, often up to 90 days.

What happens if I miss the reporting deadline?

Missing a reporting deadline can lead to regulatory penalties and may affect the safety profile of the product.

Can I report an adverse event anonymously?

Yes, many regulatory agencies allow anonymous reporting of adverse events to encourage reporting without fear of repercussions.