RWE 101 – Postmarket Requirements (PMR) vs Post-Authorisation Safety Studies (PASS)


In the context of real-world evidence (RWE) and regulatory frameworks, postmarket requirements (PMRs) and post-authorization safety studies (PASS) are two distinct concepts that focus on monitoring and assessing the safety and effectiveness of medical products after they have been approved or authorized for use. Here’s an explanation of each:
Postmarket Requirements (USA): Postmarket requirements refer to the obligations imposed by the US FDA on manufacturers or sponsors of medical products (such as drugs and biologics) after they have been approved for marketing. These requirements are intended to gather additional data and monitor the product’s safety and effectiveness in real-world settings and INCLUDE observational studies that sponsors are required to conduct.
Compliance with these requirements ensures ongoing evaluation and surveillance of the product’s safety and effectiveness throughout its lifecycle.
Post-Authorization Safety Studies (EU): Post-authorization safety studies (PASS) are specific studies conducted to further assess the safety profile of a medical product in real-world settings after it has been authorized for use. PASS is a type of post-marketing study designed to gather additional safety data that may not have been captured during pre-market clinical trials due to the limited sample size, restricted patient population, or duration of the trials.
Key aspects of post-authorization safety studies include:

Study design: PASS typically involves observational study designs, such as cohort studies or case-control studies, to evaluate the safety outcomes associated with the product’s use in a larger patient population.

Sample size: PASS often involves a larger number of participants than pre-market clinical trials to increase the likelihood of detecting rare or long-term safety events.

Data collection: Data for non-interventional PASS is collected from real-world sources, such as electronic health records, claims databases, registries, or other healthcare databases.

Safety outcomes: The primary focus of PASS is to assess and monitor the occurrence of safety events, adverse drug reactions, or any potential safety concerns associated with the product’s use.
Post-authorization safety studies are typically conducted as a regulatory requirement, based on the authorization conditions set by the EMA (i.e., Category 1 and 2 PASS). The findings from these studies contribute to ongoing risk-benefit assessments of the product and inform regulatory decision-making, labelling updates, or risk management strategies.
Overall, postmarket requirements encompass a broader set of obligations imposed on manufacturers after a product’s approval, while post-authorization safety studies specifically focus on conducting additional studies to assess the safety profile of authorized medical products in real-world settings.

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