Differences between PSUR and PADER

Differences between PSUR and PADER

Preapproval reports include IND Annual Reports in the U.S. and Annual Safety Reports (ASRs) in Europe. Some of these documents may provide cumulative information, while others contain aggregate information specific to the reporting period. Postapproval cumulative reports of safety include NDA Periodic Adverse Drug Experiences Reports (PADERs) in the U.S. and Periodic Safety Update Reports (PSURs) in many other countries, including in Europe. Their purpose is to update and evaluate the worldwide safety experience with a medicine at defined time points after approval.

These reports provide succinct summary information together with an evaluation of the benefit-risk
profile of approved medicines in the light of new or changing postapproval information.This evaluation is designed to help ascertain whether further investigations need to be carried out and whether changes should be made to the approval and/or to the medicine’s labeling.

In summary, the aim of cumulative reports of safety is to:
• Report all the relevant new information from appropriate sources.
• Relate these data to patient exposure to the medicine.
•  Summarize the medicine’s approval status in different countries and any significant variations  related to safety.
• Create periodically the opportunity for an overall reevaluation of safety.
• Indicate whether changes should be made to an approved medicine’s label in order to optimize the use of the product.

Source: FDA and EU Guidelines