There exist regional and universal guidelines emphasizing the type and nature of data that needs to be submitted in the Periodic update reports (or so called ‘aggregate reports’). Few of those are listed below:
- EMA’s Good Pharmacovigilance Practices – Management and reporting of adverse reactions to medicinal products (Rev 1), Periodic safety update report (rev 1) & Post-authorization safety studies (Rev 1)
- USFDA 21 CFR 314.80 – Post marketing reporting of adverse drug experience; PADER/PAER are required for submission quarterly for initial 3 years and later annually. However, the period of reporting may vary if regulatory requests information for safety concerns
- As per MHRA, the PBRER is submitted every 6 months till product is placed in market, every 6 months for next two years and then annually for following 2 years
- For those globally following ICH E2C (R2) – PBRER submission is required twice in a year, annually and may be less frequently depending on different regions. The frequency of submission may change based on newer information, newer indication and/or population etc.