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, or even 03 or 07 calendar days. While most of the countries consider the concept of ‘Calendar Days’, we also have few countries following the concept of ‘Working Days’. In case of veterinary medicinal products, one needs to report the serious unexpected reports within 15 calendar days to the USFDA.

Asymmetry in submissions has been noted even in the case of aggregate safety 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 USFDA too requires quarterly PADER reports to be submitted within 30 calendar days. Although the Medicines Control Authority of Zimbabwe follows the ICH E2C-R2 timelines, the ad-hoc PSURs are required to be submitted within 30 calendar days.

The reporting timelines for updated version of the risk management plans (RMP) are not specified in any country’s pharmacovigilance guideline. The Marketing Authorization Holder (MAH) may choose any of the following options in such scenarios:

1. Not to update the RMP
2. To not submit the updated version in some countries
3. Check with the respective regulatory agency, or
4. Undertake the submission to all the regulatory agencies at the same time.

Besides, the reporting timelines are quite different for device vigilance as well as cosmetovigilance. The ultimate goal is timely reporting to the regulatory agencies, by the 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 and in the interest of Patient Safety!