RWE 101 – Categories of PASS

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.

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