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Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

22 April 2021
Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete the test for “heavy metals” (HMs, general chapter 2.4.8) in monographs on substances “for veterinary use only”. The 16 monographs concerned have been published in Pharmeuropa 33.2 together with other new texts and technical revisions of the Ph. Eur. The deadline for comments is 30 June 2021.

This public enquiry is the most recent stage in the implementation strategy endorsed by the Ph. Eur. Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on elemental impurities (EI) by the ICH. Marking a true paradigm shift for the control of EI, implementing the guideline immediately became a top priority for the Ph. Eur. Commission.

The first milestone was reached in 2015 with the deletion of the wet chemical tests for heavy metals from individual monographs for human and veterinary use, with the general monograph Substances for pharmaceutical use (2034) revised to state that such individual monographs would no longer contain specifications for EI unless otherwise prescribed. At that time, and in accordance with the scope of ICH Q3D (reproduced in general chapter 5.20), an exception was made for monographs on substances “for veterinary use only”. However, manufacturers were nonetheless reminded, with a new statement in the production section of general monograph 2034, of the importance of controlling EI levels in the substance via an appropriate control strategy. The general monograph Pharmaceutical preparations (2619) was also revised to include a requirement for manufacturers of medicinal products to control the levels of EI in their products using the principles of risk management.

More recently, on 23 January 2020 (EMA/CVMP/QWP/631010/2017-Rev.2), the CVMP decided to phase-in implementation of the risk assessment requirements for the control of EI in veterinary medicinal products. Since 1 January 2021, new marketing authorisation applications for such products submitted in the European Union must comply with these requirements and all veterinary medicinal products will have to comply by January 2023. The Ph. Eur. is therefore now proposing to delete the cross-references to the test for HM (2.4.8) in the 16 monographs on substances “for veterinary use only” that include such a test, hence their publication in Pharmeuropa.

The Ph. Eur. also continues to roll out its ICH Q3D implementation strategy for other items in the action plan, such as excipients of natural origin (see news from March 2020).

Users are invited to submit their comments before the deadline of 30 June 2021.

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