[Sense and nonsense in post-authorization surveillance]

Area of Science:

• Pharmacovigilance
• Pharmaco-epidemiology

Context:

• Post-authorization surveillance studies observe medication use as labeled.
• These studies are non-interventional, not influencing patient treatment decisions.
• They are distinct from Phase IV clinical trials.

Purpose:

• To differentiate surveillance studies from Phase IV clinical trials.
• To explain the regulatory status of surveillance studies under German Drug Law and GCP.
• To highlight their role in pharmacovigilance within European regulatory policies.

Summary:

• Surveillance studies are pharmaco-epidemiological investigations using patient data.
• They are not subject to standard clinical trial regulations (e.g., German Drug Law, GCP).
• In Germany, they can extend or substitute safety and efficacy documentation if quality criteria are met.

Impact:

• Surveillance studies can influence regulatory decisions regarding drug safety and efficacy in Germany.
• They provide a valuable reference for physicians assessing study value, even outside regulatory contexts.
• Newly defined quality criteria are crucial for their acceptance in regulatory submissions.