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
RCTs: Can the treatment work? Patient registries: Does the treatment work?
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
In the Bookstores
Regulatory Matters
Medical Communications
The Webscout
Teaching Medical Writing
Good Writing Practice
Out on Our Own


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