Europe – Revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4 – Second targeted stakeholders’ consultation

Annex 1 was first published in 1971, to ensure sterility of medicinal products placed on the market for the benefits of patients.

Since then it has undergone a number of targeted updates but, until now it has not undergone a full review. This revision is intended to add clarity, introduce the principles of Quality Risk Management to allow for the inclusion of new technologies and innovative processes and to change the structure to a more logical flow. Key changes are:

  • Introduction of new sections;
  • Introduction of QRM Principles;
  • Restructured to give more logical flow;
  • Added detail to a number of the previous sections to provide further clarity.

A first targeted consultation conducted from 20 December 2017 to 20 March 2018 allowed about 140 companies and/or organizations to comment. The drafting group processed more than 6200 lines of comments.

Due to widespread interest from industry following the first targeted consultation, and because of substantial modifications introduced in several sections, it was agreed to engage with stakeholders a second targeted consultation on the updated draft guidance (version 12) focused on the sections and/or significantly modified paragraphs that raised most concerns by stakeholders.

The second targeted consultation aims at collecting experience from the sectors on certain manufacturing steps. The European Commission therefore expect to receive contribution from the European associations representing the sectors…