On the 28th January 2013, the EMA published it's "
Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies"
According to the EMA:
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.
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).[1]
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".[2]
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.
All headings and sub-headings of the format presented in this guidance should always be included and the same numbering should be used. Additional sub-headings can be added as necessary. Where a heading or sub-heading does not apply to the study, it should still be included but "Not applicable" should be stated with a short justification. The same format for dates should be used throughout the report. The format "DD Month YYYY" (e.g. 01 January 2013) is recommended. The format DD-MMM-YYYY (e.g. 01-JAN-2013) may be used.
Annex 1 should be used to list clearly identifiable stand-alone documents not included in the final study report and available upon request, e.g. contact details of all responsible parties and of all investigators, or section 9.10. In this case, a summary should be provided in the corresponding section of the final study result and reference should be made to Annex 1. Other annexes can be added.
The final study report should be signed by the principal investigator. The qualified person in pharmacovigilance (QPPV) or his/her delegate should receive a copyof the report.
The text in italics and inserted between square brackets is intended to guide the reader on the principal points to be considered for writing that section of the final study report. It should be deleted if this guidance is used as a template.
For questions on this guidance, contact p-pv-helpdesk@ema.europa.eu with the Subject "Questions on guidance for PASS submission".
This guidance may be later revised based on comments and experience.
EMA PASS Useful Links
All of the above references and more can also be found at:
