A GLP memorandum of understanding between an OECD-member country and the U.S. would permit acceptance of final reports and data conducted in either country under their applicable GLP regulations. This means acceptance of data:

• A. In either country under their GLP regulations
• B. Only in the U.S. under U.S. GLP regulations
• C. Only in OECD member countries under OECD GLP regulations
• D. Not cross-accepted between countries

Answer: (A)

The key idea here is mutual recognition of GLP data between the United States and an OECD member country. When a GLP memorandum of understanding exists, final reports and data produced in either country under that country’s GLP regulations are acceptable in the other country’s regulatory system. In practice, this means a study conducted in one jurisdiction can be used to support regulatory decisions in the other, as long as it was performed under the relevant GLP rules and is properly documented. So data from the U.S. can be accepted in the OECD member country and data from that country can be accepted in the U.S., without needing to redo the study under the other country’s GLP framework.