Medical Writing Observational Studies Reporting non-interventional post-authorisation safety studies (NI-PASS)

Volume 26, Issue 3 - Observational Studies

Reporting non-interventional post-authorisation safety studies (NI-PASS)


Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to collect data on approved products. NI PASS study reports should be drafted according to a particular mandated format, which may not be intuitive for writers more familiar with clinical study reports for interventional trials. This article addresses the structure of NI-PASS reports, comparing and contrasting with the clinical study reports of interventional trials.
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  1. Guideline on good pharmacovigilance practices (GVP): Module VIII – Postauthorisation safety studies (Rev 1). 19 April 2013. EMA/813938/2011 Rev 1. Available from: Available from:
  2. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Communities L 311/67. 28.11.2001. Available from: Available from:
  3. EU PAS Register Guide. European Medicines Agency. 28 July 2014, EMA/613603/2012. Available from: Available from:
  4. Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies. 30 July 2013. EMA/48663/2013. Available from: Available from:
  5. Guidance for the format and content of the protocol of non-interventional postauthorisation safety studies. 26 September 2012. EMA/623947/2012. Available from: Available from:



Observations and Observational Studies
President's Message
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Odd cases and risky cohorts: Measures of risk and association in observational studies
Guidance for the design and analysis of observational studies: The STRengthening Analytical Thinking for Observational Studies (STRATOS) initiative
Guidelines for disclosing the results from observational trials
Registration and ethics committee approval for observational studies: Current status and way forward
Regulatory submissions of non-interventional post-authorisation safety studies
Reporting non-interventional post-authorisation safety studies (NI-PASS)
Patient-reported outcomes: How useful are they?
EMA releases the revised Good Pharmacovigilance Practices Module V – updated guidance on risk management plans
Mentoring tomorrow’s medical writers
ICMJE to mandate data sharing statements
News from the EMA
Journal Watch
Getting Your Foot in the Door
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