ICH E2E - Pharmacovigilance Planning

What it says

E2E provides a structure for planning pharmacovigilance activities, especially in preparation for the early post-marketing period of a new medicine. It describes the safety specification, a summary of the important identified risks, potential risks and missing information, and the pharmacovigilance plan, which sets out the activities to address those safety concerns.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Planning starts during development, not after approval.
• Routine pharmacovigilance may be enough for some products, while others need additional studies.
• The plan should be revisited as new safety information arrives.

What inspectors look for

• Whether the safety specification reflects the knowledge about the product.
• Whether planned activities were carried out.
• Whether the plan was updated over time.

Related regulations