参照FDA Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers 原料药和制剂稳定性试验 问题与解答：

答案是肯定的。

Q7 Are there changes to postapproval protocols and commitments when ICH stability guidances are implemented because of scale or type of batches submitted?
A7: ICH Q1A(R2), section II, B, 8, Stability Commitment (2.2.8) addresses this question. Section 2.1.8 provides information regarding stability commitment for drug substances.
Also, ANDAs and DMFs should include a commitment to place one batch of drug product and drug substance, respectively, into the annual long-term stability program, and to provide stability data in the annual reports.

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