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.
Current |
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 ktm@usp.org.