From 10 January 2013, marketing authorisation holders have the obligation to comply with the format of the final study report for non-interventional post-authorisation safety studies (PASS), as specified in Art 36 to 38 and Art 40 of the Commission Implementing Regulation (EU) No 520/2012. EMA releases a guidance for the format and content of the final study report of non-interventional post-authorisation safety studies. See link below
This document provides guidance for writing the final study report for non-interventional PASS in order to support the consistency of the information provided and facilitate its assessment. The guidance is based on Annex III(3) of Commission Implementing Regulation No 520/2012 with the additional instructions of Module VIII of the Good pharmacovigilance practices (GVP).
This document also provides guidance for the Format of the abstract of the final study report referred to in Annex III(2) of Commission Implementing Regulation No 520/2012 (see Section 1. Abstract). This abstract serves as the abstract of the study results to be published by the Agency. For this purpose, the abstract should be uploaded in the “Study results” section of the EU PAS register. The marketing authorisation holder should also upload the full final study report in the register as an “Other document”.
The final study report should provide enough information on the design, conduct and analysis of the study so that there is no ambiguity in how the research question was addressed and how the study was carried out. In describing the research methods (section 9), it may be sufficient to restate in each section the corresponding description of the protocol if it is still valid. It is also possible to include the final version of the protocol in an Annex and summarise the main features of the study design in the final study report with references to the corresponding section of the protocol. Where the study was conducted or analysed differently from the specifications included in the protocol, this should be clearly mentioned and the deviations should be described.
The final study report should be signed by the principal investigator. The qualified person in pharmacovigilance (QPPV) or his/her delegate should receive a copy of the report.