European Pharmacopoeia Chapter 5.20 "Metal Catalysts or Metal Reagent Residues": Implementation Delayed Until Further Notice!

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

The draft of ICH-Q3D "Guideline for Elemental Impurities", recently published,  set a change in strategy at the European Pharmacopoeia Commission with regard to Chapter 5.20 "Metal Catalysts or Metal Residues" and General Monograph 2034 "Substances for pharmaceutical use".

The starting point was the decision of EMA's Committee for Medicinal Products for Human Use (CHMP) to delay the application of  the "Guideline on the specification limits for residues of metal catalysts or metal reagents" (EMEA/CHMP/SWP/4446/2000) - in force since 2008 - to already existing marketed medicinal products. A 5-year transition period is described in the Guideline which means that it should have become applicable to all existing marketed products as of 1 September 2013. In its last session, the CHMP decided not to end the transition period until the ICH Q3D guideline will have been finalised.

In April 2012, the European Pharmacopoeia Commission had already decided to reproduce the requirements of this EMA Guideline in Chapter 5.20. Reproducing a Guideline in a Ph. Eur. Chapter doesn't make it legally binding as long as the Chapter is not referenced in a Ph. Eur. monograph. Monograph 2034 with reference to revised Chapter 5.20 had been adopted by the Ph. Eur. Commission in March 2013, which means that Chapter 5.20 would have become mandatory on the implementation date as of 1 April 2014! As neither the finalized ICH Q3D Guideline  nor the application of Chapter 5.20 to existing medicinal products won't be existent until that date, the chapter would be totally useless. To solve this dilemma, the European Pharmacopoeia Commission thus decided not to publish General Monograph 2034 in the Ph. Eur. Supplement 8.1. As a consequence, chapter 5.20 won't become legally binding as of 1 April 2014.

More details about this strategic decision can be found in the latest press release of the European Pharmacopoeia Commission.