Under the MHRA Yellow Card Scheme, which statement best describes reporting for newly licensed medicines?

• A. Only report adverse reactions if they are serious
• B. Report only adverse reactions that are unexpected
• C. Do not report mild events
• D. All adverse reactions, regardless of severity

Answer: (D)

The main idea is that safety monitoring relies on collecting every suspected adverse reaction to a medicine, especially when the drug is newly licensed. The MHRA Yellow Card Scheme invites reporting of all adverse drug reactions, not just the serious or unexpected ones, because early, comprehensive data helps detect safety signals as real-world use expands. Reporting all reactions, regardless of how mild they seem, allows researchers to see patterns, estimate true frequency, and identify subgroups at risk, which can lead to updates in labeling, warnings, or dosing if needed. Limiting reports to only serious or only unexpected events would miss useful information and slow signal detection, so the best description is that all adverse reactions, regardless of severity, should be reported.