In the case of a global marketing application, records must be kept for how long after the last regulatory agency approval?

In the case of a global marketing application, records must be kept for how long after the last regulatory agency approval?

• A. One year
• B. Two years
• C. Five years
• D. As long as necessary

Answer: (B)

In the context of a global marketing application, the requirement to keep records for two years after the last regulatory agency approval is based on the guidelines established by the International Council for Harmonisation (ICH) E6. This duration is considered adequate to allow for any potential audits, inspections, or issues that may arise after approval. It ensures that all data related to the clinical trial and its results remain accessible during this period for regulatory review or safety monitoring. This timeframe provides a balance between ensuring proper record-keeping for regulatory compliance and allowing companies to manage their documentation efficiently. It is important to note that while some regulations may specify shorter or longer durations, the two-year guideline aligns with the ICH’s focus on data integrity and the ongoing responsibility of sponsors to monitor the safety and efficacy of their products even after approval.

In the context of a global marketing application, the requirement to keep records for two years after the last regulatory agency approval is based on the guidelines established by the International Council for Harmonisation (ICH) E6. This duration is considered adequate to allow for any potential audits, inspections, or issues that may arise after approval. It ensures that all data related to the clinical trial and its results remain accessible during this period for regulatory review or safety monitoring.

This timeframe provides a balance between ensuring proper record-keeping for regulatory compliance and allowing companies to manage their documentation efficiently. It is important to note that while some regulations may specify shorter or longer durations, the two-year guideline aligns with the ICH’s focus on data integrity and the ongoing responsibility of sponsors to monitor the safety and efficacy of their products even after approval.