RWE 101 – PASS Approval Requirements


Post-authorisation safety studies (PASS) are studies conducted after a medicine has been authorized (licensed) with the goal of acquiring more data about the medicine’s safety, or to measure the effectiveness of risk-management measures. These studies play a vital role in understanding the safety and effectiveness of a drug in a real-world context.
While specific requirements can vary by country, they often include:
[1] Ethics Committee Approval: Any study involving human subjects generally needs to be approved by an Ethics Committee (EC) or Institutional Review Board (IRB). This body ensures that the study is designed and implemented in a manner that respects the rights, safety, and well-being of the participants (i.e., compliance with the Declaration of Helsinki).
[2] Regulatory Approval: Depending on the country and type of PASS (e.g., Category 1, 2, 3, or voluntary PASS) additional regulatory approval may be needed. For instance, in the European Union, any category 1 or 2 PASS protocol of a medicine authorised through the Centralised Procedure has to be approved by the European Medicines Agency (EMA).
[3] Data Protection Laws Compliance: Studies must comply with all relevant data protection laws (e.g., GDPR). This includes regulations on the use and sharing of personal data, as well as provisions for protecting the privacy of participants.
[4] Study Registration: Most categories of PASS must be registered in a public database (i.e., EU PAS Register). This increases transparency and allows for the tracking and sharing of results.
[5] Adherence to Good Pharmacovigilance Practices (GVP): This is especially pertinent in the EU, where PASS must adhere to Module VIII of the GVP.
[6] Provision of Adequate Information to Participants: There’s usually a requirement that all participants must be given adequate information about the study, and that informed consent must be obtained.
[7] Reporting Requirements: There will be requirements to report adverse events, progress, and the final results to the respective regulatory bodies (i.e., ethics committees and national competent authorities).
However, these requirements can be subject to change over time and may vary in specifics from one country to another. Therefore, it’s crucial to consult with the appropriate regulatory body or a regulatory affairs professional familiar with these regulations when planning a post-authorisation safety study.

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