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Pharmacopeial Discussion Group Working Procedures Changes

Type of Posting: General Announcement
Posting Date: 26–Jan–2018

The Pharmacopeial Discussion Group (PDG) [European Pharmacopoeia (Ph.Eur.), Japanese Pharmacopoeia (JP), and the United States Pharmacopoeia (USP)] has agreed to the implementation of significant changes to the work structure, including:

  • Eliminating two stages of PDG harmonization process to streamline and reduce the level of complexity.
  • Restructuring meeting format to engage more effectively at the technical level with regards to resolving issues on specific topics.
  • Maintaining a twice-yearly meeting frequency with a focus on strategic direction setting.

Effective April 1, 2018, PDG will utilize a reduced 5-stage approach for harmonization of retrospectively for existing monographs or chapters or prospectively for new monographs or chapters.

In this new structure, the current Stage 1 and Stage 2 will be officially removed and handled more informally within PDG. The previous stages 4, 5 and 6 are now labeled 2, 3 and 4.

The current PDG stage structure and the new stage structure are below.


New (Effective April 1, 2018)

Stage 1: Identification Stage 1: Preparation of First Draft
Stage 2: Investigation
Stage 3: Proposal for Expert Committee Review
Stage 4: Official Inquiry Stage 2: Official Inquiry
Stage 5: Consensus Stage 3: Consensus
Stage 6: Regional Adoption and Implementation Stage 4: Regional Adoption and Implementation
Stage 7: Inter-Regional Acceptance Stage 5: Inter-Regional Acceptance

Should you have any questions or comments, please contact Kevin T. Moore, Ph.D., Senior Manager, Pharmacopeial Collaboration at 301-816-8369 or