EMA: New Q&A Clarify Regulatory Expectations on API Mixes
New Q&A clarify how mixtures of active pharmaceutical ingredients (APIs) and excipients (“API mixes”) should be handled from a regulatory perspective. An API mix is defined as a mixture of an API with one or more excipients and is considered the first step in the manufacture of a finished product.
Submission via an ASMF or CEP may be acceptable in certain cases, particularly when the mixture is required for safety or stability reasons. In such cases, manufacturing may be performed under EU GMP Part II (or Regulation (EU) 2025/2154 for veterinary products). If the mixture is sterile, GMP Part I requirements apply to sterilisation and subsequent steps.
The Q&A also clarify documentation requirements, including justification of excipient choice and levels, stability data where relevant, and transparency regarding the mixing process and control strategy in the dossier.
API mixes justified solely by workability or handling reasons are generally not acceptable.
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