Whenever we think about expedited reporting of adverse event reports, the first number that comes to our mind is 15. This is mainly because ‘most’ of the regulatory agencies require serious reports to be submitted within 15 Calendar Days, and non-serious reports within 90 Calendar Days.

The term ‘most’ is the appropriate term as there are many regulatory agencies that expect reports earlier than 15 Calendar Days, even if these do not pertain to serious adverse event reports associated with Clinical Trials.

One should not be surprised to note that some regulatory agencies expect serious adverse event reports to be submitted or notified within 24 hours. While most of the countries consider the concept of ‘Calendar Days’, we also have few countries following the concept of ‘Working Days’.

Serious Adverse Event Reports

Non-Serious Adverse Event Reports

Asymmetry in submissions has been noted even in the case of Periodic Reports or PSURs. Most countries have now adopted the ICH E2C-R2 timelines of 70 Calendar Days (< 1 Year duration) or 90 Calendar Days (>1 Year Duration). However, we have some countries (India, South Africa, etc) that require Periodic Reports to be submitted within 30 Calendar Days.

The ultimate goal is timely reporting of Adverse Event Reports and Periodic Reports by the Marketing Authorization Holders (MAH). In such a scenario, it may be ideal to harmonize the submission timelines for all kinds of reports so that it is administratively efficient.