Retention period harmonisation across countries is not anticipated given that the periods “defined by an applicable regulatory authority” are based on: country-specific legal requirements of the registration receiving organisation, the nature of the specific GLP program (human health, animal health, agricultural chemicals, GMO etc.) and approaches aimed at minimising burdens on the regulated industry.
Study records must be retained in compliance with the requirements of receiving authorities. Study records and other supporting material should be retained for as long as regulatory authorities might request GLP audits of the respective studies.
