ICH E2D(R1) - Post-Approval Safety Data Management

What it says

E2D(R1) provides definitions and standards for managing and reporting safety information after a medicine is approved, including adverse event and adverse reaction definitions, sources of case information such as spontaneous reports, literature and solicited reports, the minimum information needed for a valid case, and expectations for expedited reporting and follow-up.

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

What it means in practice

• Safety information can arrive from many places, including complaints, social media and the literature, and each needs a path to the safety system.
• A valid case needs an identifiable reporter, an identifiable patient, a suspect product and an event.
• The clock for expedited reporting can start when any part of the company receives the information.

What inspectors look for

• Whether information from all sources reaches the safety function.
• Whether valid cases are reported within required timelines.
• Whether follow-up of incomplete cases is made and documented.

Related regulations