In 2021, PDG launched a pilot programme inviting other world pharmacopoeias to join the existing panel of members in developing robust, science-based, harmonised pharmacopoeial standards. In 2023, the Indian Pharmacopoeia Commission (IPC) joined as the PDG’s fourth member. This new collaboration provided invaluable insights and laid the foundations for a new global initiative. Additionally, the PDG led the maintenance of the ICH Q4B guideline and its 16 annexes, involving 9 global pharmacopoeias in the harmonisation of these critical texts. Entrusted with this task by the International Council for Harmonisation (ICH), the purpose of this guideline and its annexes is to achieve regulatory interchangeability among 15 regulatory authorities.
This event offered a unique interactive opportunity to engage with representatives from four global pharmacopoeias, i.e. the Ph. Eur., IPC, JP, and USP. Participants had the opportunity to hear about the latest milestones achieved by the PDG.
Key topics discussed include:
- Feedback on the PDG’s expansion pilot: celebrating the successful inclusion of the Indian Pharmacopoeia Commission (IPC) as the fourth member in October 2023.
- Future expansion plans: updates on the next steps and further programmes for the PDG’s expansion, including lessons learned from the pilot phase and outreach to additional global pharmacopoeias.
- ICH Q4B(R1) background: insights into the new ICH Q4B(R1) guideline, developed by the PDG with the involvement of 9 global pharmacopoeias focussing on harmonising 16 annexes.
- Technical challenges: discussion on the technical challenges encountered by the PDG in the harmonisation process.
- Collaboration opportunities: how to collaborate with the PDG and support the harmonisation of excipient monographs and general texts, including anticipated developments in the PDG’s interaction with stakeholders.
Target audience
This webinar is of interest to professionals from the pharmaceutical industry, including pharmacopoeial and regulatory affairs staff, laboratory scientists and QC managers. It will also be of interest to those involved in harmonisation across regions.
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Additional information
- The Pharmacopoeial Discussion Group (PDG) - History & Purpose
- Framework for the PDG Pilot to Introduce New Members
- News Item: Pharmacopoeial Discussion Group welcomes Indian Pharmacopoeia Commission as a member, facilitating reach and enhancing impact of pharmacopoeial standards harmonisation, 5 October 2023
