EMA: Comments on Q&As for 'Co-processed Excipients' possible

In September 2024, the EMA (European Medicines Agency) published the document 'Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V)' on its website for comments. Remarks and comments can be submitted until 31 December 2024.

The question and answer catalogue refers to dosage forms of 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 single used excipients.

The document consists of the following chapters and annexes:

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).

The complete catalogue of questions and answers 'Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V)' can be found on the EMA website.