Post-authorisation safety studies (PASS): Update on Assessment Timelines and Submission Requirements

Key changes

Updated Question 11 clarifies that the assessment of a non-interventional imposed PASS final study report by the PRAC takes up to 74 days, followed by 67 days for the European Commission decision-making process. Updated Question 12 specifies that draft protocols for these studies should be submitted in Module 1.8.2 of the CTD and only included in the RMP once endorsed by the PRAC.

PV impact

MAHs must align their submission planning for non-interventional imposed PASS with the clarified assessment timelines. Draft protocols must be correctly placed in the CTD (Module 1.8.2) and RMP updates should only occur after PRAC endorsement.

Exact policy details

Effective date of Revision 2

9 August 2016

Applies to: Applicable to submission of information on non-interventional post-authorisation safety studies (PASS)

Date for coming into effect of Revision 2: 9 August 2016. · p. 1 · High · Source

Submission of final study report

12 months after end of data collection

Applies to: Final study report for non-interventional PASS conducted under obligation

The final study report shall be submitted within 12 months after the end of data collection. · p. 2 · High · Source

Submission of study protocol and progress reports

As required by national competent authorities

Applies to: All non-interventional PASS conducted voluntarily

The national competent authority may require submission of the study protocol and the progress reports. · p. 2 · High · Source

Study registration in the EU PAS Register

Before study commences or at earliest possible date

Applies to: Non-interventional PASS

Non-interventional PASS should be registered before the study commences or at the earliest possible date. · p. 2 · High · Source

Workflow rule impacts

Extracted documents

• Post-authorisation safety studies (PASS) | European Medicines Agency (EMA)htmlhtml · high · 1 page
• Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 2)pdfpdf_text · high · 3 pages
• European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changesdocxdocx · high · 1 page
• Guidance to applicants /marketing authorisation holders (MAHs) on oral explanations at EMApdfpdf_text · high · 2 pages