Module 6

02/10/2024

Lifecyle: Post Authorisation Safety Studies (PASS) Types of PASS where derived data gets updated into the product information

• A PASS is a study conducted after marketing authorisation is granted in order to obtain further information on safety OR to measure effectiveness of risk-management measures. • PASS can be imposed by PRAC derived from the MA assessment; a post-authorisation commitment or a specific obligations as part of the conditional approval of the MA. It is mandatory and in some cases could be a subject to penalties. • A pass can be voluntarily proposed by MAH. Not legally enforced but advantageous to the product information. • Studies are outlined in the product’s risk management plan (RMP). • Protocol and final study results/report are assessed by PRAC. • Results of PASS studies have to be submitted within 12 months of end of data collection • PASS studies are generally observational studies but recent developments have moved away from this and in some rare cases RCTs are imposed where there are safety gaps in the product information.

RMP Cat.

Type

Status

1

Imposed PASS

Mandatory & subject to penalties

2

Specific Obligation

3

Required

Legally enforceable

4

Stated

Not enforced

The Organisation for Professionals in Regulatory Affairs

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Lifecyle: Post Authorisation Efficacy and Safety Studies Summary of the milestones for PAES and PASS

1 • PASS/PAES study proposed/imposed

2 • Seek Scientific Advice on study design (optional)

3 • Submit protocol & agree design (~60 days)

Costly Studies and

• Conduct study

resource intensive

4

5 • Submit interim results (in PSUR and/or interim reports)

6 • Submit results to agency (Type II, CSR)

7 • Update product information as appropriate

• Update to EPAR

8

The Organisation for Professionals in Regulatory Affairs

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