Aggregate Report / Periodic Report
Periodic Safety Reports – Impact on Risk-Benefit Balance
Periodic Safety Reports, also known as Aggregate Reports, is one of the backbones and fundamental pillars of the pharmacovigilance process to monitor the safety profile and risk-benefit balance of all medicinal products.
Frequency and Submission Timeline
For each marketing authorisation holder or applicant, regulatory authorities expect the annual submission of "Periodic Safety Report" starting from the initial product development phase until completion of all phases in clinical trials within 60-calendar days from data-lock point as per local requirement. It is also required to submit the "Periodic Safety Report" for all authorised products since its date of approval until the license of product remains valid into the market for respective marketing authorisation holder as per local requirement within 30 / 60 / 70 / 90-calendar days from the data-lock point as per local requirement.
Scheduling of Periodic Safety Reports
To achieve the compliance of each Periodic Safety Report, it requires to prepare a schedule or calendar following the EURD List or as per local requirement for all applicable products covering the minimum required information like product authorisation details, legal basis, duration of report, data-lock point, regulatory submission due date, actual submission date, contractual agreement or SDEA in place, regulatory commitment etc.
Practical Challenges while Authoring and Submission of Periodic Safety Reports
Periodic Safety Reports requires contribution of source data from various in-house business functions and different stakeholders like Regulatory Affairs, Regulatory Compliance and Safety Information, Clinical Development, Clinical Data Monitoring, Medical Affairs, Medical Literature Monitoring, Sales, Labelling Team, ICSR Team, Signal Management, and Risk Management Team etc.
The above-mentioned process from the management of Periodic Report Schedule, then timely initiation for the preparation of report, then to collect the required source data from multiple stakeholders, then their inclusion with the relevant data in Periodic Safety Reports and followed by its critical analysis to evaluate the benefit-risk assessment adds the complexity to the operations process along with the timely submission for the management of regulatory compliance.
Periodic Safety Reports requires submission as a separate eCTD sequence file for each procedure, via Electronic Submission Gateway or Syncplicity Web Client Portal or as per local requirement.
Post-submission Health Authority Request
Post-submission of each Periodic Safety Report, regulatory authority may raise a "Request for Supplementary Information (RfSI)" as a preliminary assessment of PSUSA Procedure or regulatory authority may raise a PSUR Follow-up procedure (PSUFU) as an outcome of PSUSA Procedure
Our Solution for Different Types of Periodic Safety Reports and its Complete Activity
AllyWorth, supported by the team of experienced professionals, takes an accountability of regulatory compliance and post-submission requirements like PSUSA / PSUFU / any other additional authority request for all the different types of Periodic Safety Reports or Aggregate Reports listed below as per local requirement.
- Periodic Adverse Drug Experience Reports (PADERs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Periodic Safety Update Reports (PSURs)
- Canadian Annual Safety Report (ASR)
- Addendum to Clinical Overview Summary (AdCO / ACOS) for Renewal
- Summary Bridging Reports (SBRs)
- PSUR Annual Addendum Reports (ARs)
- Development Safety Update Report (DSUR)
- Signal Management Reports
- Other Safety Assessment Reports
Considering all these functional requirements together for each "Periodic Safety Report", it makes the entire process of periodic safety reporting a more challengeable particularly for the mid-to-complex size Global or Local Pharmaceutical Industry and Healthcare Organisation. Therefore, it is crucial to collaborate with a seasoned and trustworthy service provider like AllyWorth to secure the optimal regulatory compliance.