CHMP adopts ICH Q3D Guideline as "Scientific Guideline"

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Wednesday, 25 May 2022 9 .00 - 16.30 h

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Establishment, Use and Maintenance of Analytical Reference Substances

After the publication of a final ICH guideline, its implementation into the respective national regulations of the 3 ICH regions Europe, USA and Japan (Step 5 of the ICH process) is usually the next step. The "ICH Guideline for elemental impurities - Q3D" was published on 19 December 2014 as Step 4 document. Four weeks later - on 12 January 2015 - the integration of the Guideline into EMA's set of rules of "Scientific Guidelines" was notified after the CHMP committee had adopted it through a formal act.

As for all the ICH guidelines which are integrated into the collection of "Scientific Guidelines", the corresponding EMA Guideline which is now entitled "ICH guideline Q3D on elemental impurities" is composed of only one table of the document history and the section "scope" identical to that of the original ICH guideline. After that, there is just a direct link to the ICH page containing the "Quality Guidelines" where the Q3D can be easily found.

The table with the document history contains important information for the pharmaceutical and API industry of the EU member states about the coming into force of the ICH Q3D requirements. These regulations will be binding:

• As of June 2016 for new marketing authorisation applications and
• As of December 2017 for authorised medicinal products

The time window for the verification of authorised and/ or already marketed medicinal products for compliance with the limits regarding elemental impurities/ acceptable daily doses is now only 3 years.