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EDQM Strasbourg, France 07/06/2024
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Pharmacopoeial Discussion Group achievements

The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on 15 April 2024.

The primary topic of the meeting was the lessons learned from the PDG expansion pilot programme that was launched in 2022 and ended in October 2023 with the inclusion of the Indian Pharmacopoeia Commission as the fourth member of the group. This discussion led to an exchange on how best to prepare for the inclusion of additional world pharmacopoeias that meet the entry criteria. An agreement on a framework for this next phase was one of the key outcomes of the meeting. The group will work on the details of the next phase, including updated entry criteria, in the coming months before launching a new expansion phase.

The PDG also discussed the maintenance work on the ICH Q4B annexes on pharmacopoeial harmonisation, which covers the revision of the ICH Q4B Guideline and Annex 5 of the ICH Standard Operating Procedure, taking into consideration the comments received from ICH members both at and after the ICH meeting in Prague (Czech Republic) in November 2023. The aim is to present updated drafts and an appropriate response at the next ICH meeting in Fukuoka (Japan) to finalise the proof-of-concept study.

Additionally, the agenda included an update from the nitrosamines subteam – a new initiative launched following a decision at the last annual PDG meeting in October 2023 as part of plans to enhance the future scope of collaboration on this topic – on the possible approaches and challenges related to these impurities.

Find our more by reading the press release “Pharmacopoeial Discussion Group achievements