Many regulatory agencies require companies to submit aggregate safety reports periodically for their products. Examples of aggregate safety reports include periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRER), Addendum to Clinical Overview (AdCO), Voluntary Malfunction Summary Report (VMSR), Cosmetic Product Safety Report (CPSR), developmental safety update report (DSUR), IND-Annual Report, etc.

Many misconceptions exist about aggregate safety reports. These may be related to the type of reports, type of products (device/drug/cosmetic) or the geography to which the requirements belong, etc.

Misconceptions about USPRs (also called PADERs) in the United States

1. The FDA accepts only the US Periodic Reports (USPRs)
2. One cannot submit PBRER Format of the report to the USFDA
3. If a company submits the PBRER format of the report every three years, then there is no requirement to submit annual USPRs

Misconceptions about PSURs:

1. PSUR is the old format of the report, while PBRER is the new format
2. PSUR is the format as per ICH E2C-R1, while PBRER is the format as per ICH E2C-R2
3. Both PSUR and PBRERs are different.
4. The EMA requests PBRER these days instead of PSURs
5. It is essential to learn the difference between PSURs and PBRERs
6. Nowadays, regulatory agencies require PBRERs instead of PSURs
7. The timeline for submission (days from the data lock point) of the PSUR reports is uniform across all the countries

Misconception about the European Union Reference Date (EURD) List

1. Only the countries in the European Economic Area (EEA) and the UK follow the EURD list.
2. The EURD list includes 100% of the medicinal products licensed in the EEA
3. Generic companies are not required to submit any PSURs
4. The EMA does not charge any fee for assessing the PSURs submitted as per the EURD list

Cosmetovigilance and Medical Device Vigilance

1. No aggregate safety reports are required for cosmetic products and medical devices.

Post Marketing Vs Clinical Trials

1. Aggregate safety reports are only required to be submitted once the products are commercialized.

Veterinary Medicinal Products

1. No aggregate safety reports are required for veterinary medicinal products.