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.
Different frequencies for submission of periodic reports are defined with respect to national norms and dynamic safety considerations. Extraction of meaningful data becomes important:
- To continuously evaluate the risks and benefits
- Reporting in time to regulatory
- Take actions (necessitated by company or regulatory) on significant safety issues
- Identify populations at larger risk
- Evidence that safety profile is monitored worldwide
The big question is how to ensure the genuine facts and figures for safety analysis from the ample Pharmacovigilance data an Organization has along with region wise implications. There is a need to align the data to have proper interpretation of the safety dataset gathered in six months and/or annually. Additionally, there has to be a mechanism to assure that the tabulations/listings in reports are from the original data collected in the safety reporting interval without manipulation.
For a vast database containing Pharmacovigilance data of several hundreds of molecules, this becomes extremely vital. The monitoring and tracking of safety dataset manually or via simplistic computerized system is inversely proportional to the amount of data loaded in the database.
There has to be a mechanism to track safety data (as below) as per formats in accordance to guidance documents:
- Line listing reports
- Summary tabulation reports (Clinical trial, spontaneous, literature as well as non-interventional and other solicited sources)
- Compliance monitoring of ICSRs submitted
- Safety signal detection and management
- Listings of Overdose cases, Lack of efficacy cases, Fatal cases, Seriousness and Labeling-wise event count, pregnancy and pediatric as well as other special population cases etc.
Not only that the regulatory has a suggested format and nature of data that should be submitted in these periodic reports, but also that there has to be a clear evidence that the data is reproducible and authentic.