How long must study-related records be maintained after drug approval in the U.S. according to ICH E6?

According to ICH E6 guidelines, study-related records must be maintained for a minimum of two years after the date a marketing application is approved for the drug in the U.S. This requirement is in place to ensure that adequate records are available to support claims made in the marketing application and to allow for post-marketing surveillance and further assessment of the drug's safety and efficacy. The two-year retention period strikes a balance between the need for record accessibility and practical considerations concerning data management and storage.

While longer retention periods may be advisable for certain records, particularly in cases of ongoing monitoring or for products that have raised significant safety concerns, the two-year guideline sets a foundational requirement that must be adhered to following drug approval. This timeframe enables regulatory bodies and other stakeholders to follow up and analyze the results related to the drug following its entry into the market.