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.

Real-world evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a product derived from the analysis of real-world data (RWD). RWD and RWE are playing an increasingly important role in healthcare decisions.
 
In the context of pharmacovigilance, post-authorization safety studies (PASS) are studies performed after a medicine has been approved and is available on the market. The purpose of these studies is to obtain further information on a medicine’s safety, or to measure the effectiveness of risk-management measures.
 
Post-authorization safety studies (PASS) can be interventional (clinical trials) or non-interventional. As per EMA’s GVP Module V, there are 3 categories of PASS:
 
Category 1 PASS (Imposed PASS) – These are studies required by a regulatory authority as a condition of a (normal) marketing authorization. These studies are often required to clarify the safety profile of the drug, or to assess risks that were identified in pre-approval stages, but could not be fully characterized due to limitations like sample size of clinical trials or underrepresentation of certain populations. These studies are listed in Section II.C of the risk management plan (RMP) Summary.
 
Category 2 PASS (Specific Obligations) – These are studies that are specific obligations imposed when a medicine has received a conditional marketing authorisation. This applies to medicines that target conditions with an unmet medical need – for which no treatment option exists, or where they can offer a major therapeutic advantage over existing treatments. These studies are often required because the medicines approval has been accelerated to ensure timely access by patients, limiting the amount of safety data available at the time of approval. These studies are listed as “Specific Obligations” in Section II.C of the EPAR RMP Summary
 
Category 3 PASS (Other PASS) – These are studies might be required (as opposed to being imposed) by the EMA or a national competent authority in the RMP to investigate a safety concern or to evaluate the effectiveness of risk minimisation activities.  These studies are listed as “Other Studies” in Section II.C of the RMP Summary.
 
Category 1 and 2 PASS are supervised under Articles 107m, 107n-q of Directive 2001/83/EC, meaning the protocol and study report must comply with Annex III of Regulation 520/2012/EU and EMA’s GVP Module VIII. The protocol must be approved (endorsed) by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) (medicines approved through the Centralised Procedure).
 
Category 3 PASS are supervised under Article 107m of Directive 2001/83/EC, which requires, for example, that studies are not promotional, healthcare professional renumeration is equivalent to fair market value, and final study reports should be send to the national competent authorities where the study is conducted.