EMA: Q&A 'Co-Processed Excipients' published

In January 2026, the Q&A document 'Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V)' was finally published on the EMA (European Medicines Agency) website. Comments on this list of questions and answers could be submitted until 31 December 2024, as reported in EMA: Comments on Q&As for 'Co-processed Excipients' possible. The comments received can also be viewed here. The document 'Overview of comments received on Q&A regarding co-processed excipients used in solid oral dosage forms H and V' contains these comments in tabular form.

The Q&A refers to dosage forms for human and veterinary medicinal products and points out that co-processed excipients not only have advantages but can also pose a higher risk compared to excipients used individually.

The document consists of the following chapters and appendices:

Introduction
1. What is a "co-processed excipient" in the context of these Q&As?
2. How to categorise a co-processed excipient in a finished product using a risk-based approach?
3. What are the regulatory dossier requirements to a co-processed excipient?
     3.1. The risk assessment concludes a category C (low risk CoPE)
     3.2. The risk assessment concludes a category B (medium risk CoPE)
     3.3. The risk assessment concludes a category A (high risk CoPE)
Annex I:  Risk factors and impact ranking table
Annex II: Decision tree on risk factor and impact ranking of CoPE with regard to the CQAs of finished product

In addition, Annex I provides an example for each category (A, B, C).

Please see the EMA website for the complete list of questions and answers, 'Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V)', and the corresponding comments.