Findings of EMA Inspections on Post-Authorization Safety Studies (PASS)
Post-Authorization Safety Studies (PASS) are a critical component of pharmacovigilance, required to monitor the safety of medicinal products after they have been authorized for marketing. EMA inspections frequently reveal compliance gaps in the planning, execution, and reporting of these studies. Below are common findings identified during EMA inspections related to PASS:
1️⃣ Incomplete or Delayed Submission of PASS Protocols
- Finding: Companies often fail to submit the PASS protocol on time or provide incomplete information about the study design.
- Impact: Delayed or inadequate protocols can lead to regulatory scrutiny and impact the study's ability to monitor drug safety effectively.
- Solution: Ensure that PASS protocols are comprehensive, adhere to regulatory timelines, and include clear study objectives, methods, and timelines.
2️⃣ Inadequate Risk-Based Study Design
- Finding: Some PASS studies lack a risk-based approach, failing to focus on specific safety concerns or at-risk populations.
- Impact: This can result in the study failing to provide meaningful data on important safety signals, undermining the study's value.
- Solution: Design PASS with a strong focus on identifying and evaluating key safety risks, ensuring the study is aligned with the identified safety concerns from the Risk Management Plan (RMP).
3️⃣ Poor Documentation and Data Collection
- Finding: Inconsistent or incomplete data collection methods during the PASS, often leading to missing safety information.
- Impact: Poor documentation can compromise the quality of the study results and delay regulatory assessments.
- Solution: Implement stringent data collection protocols and quality assurance processes to ensure that all relevant safety data is captured accurately and completely.
4️⃣ Non-Adherence to Study Timelines
- Finding: Delays in initiating or completing PASS studies, with some studies extending beyond the agreed timelines.
- Impact: Non-adherence to timelines can delay the detection of safety signals, potentially endangering patient safety.
- Solution: Establish and adhere to realistic timelines for PASS, with regular progress reviews and updates provided to regulatory bodies.
5️⃣ Lack of Transparency in Reporting PASS Results
- Finding: Failure to report study results transparently or submit final reports within the required timeframes.
- Impact: Lack of timely and transparent reporting can result in delayed regulatory actions, reducing the effectiveness of safety monitoring.
- Solution: Develop a clear plan for submitting interim and final reports on PASS results, ensuring timely communication with regulatory agencies.
6️⃣ Insufficient Oversight of Outsourced PASS
- Finding: Companies outsourcing PASS studies may lack sufficient oversight of third-party vendors responsible for conducting the study.
- Impact: This can lead to poor-quality data, delayed results, and non-compliance with regulatory requirements.
- Solution: Maintain clear oversight and regular audits of outsourced PASS activities to ensure compliance with study protocols and regulatory standards.
Conclusion:
EMA inspections of PASS frequently identify issues such as delayed protocols, inadequate study designs, and poor documentation. To ensure compliance, companies must prioritize proper planning, execution, and oversight of their PASS, with strong risk-based approaches and adherence to timelines.
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