These areas include development, manufacturing, distribution, and inspection and submission/review processes throughout the life cycle of APIs, drugs, biologics, and biotechnology products.

Among other changes, the revision contains additions to the following chapters of the guideline:

• Chapter 5. "Risk management methodology",
• Chapter 6. "Integration of quality risk management into industry and regulatory operations" and
• The subchapter Annex II.9 "Quality risk management as part of supply chain control".

The adopted revision will come into force by the end of July 2023.

Source:

EMA: ICH Guideline Q9