Harmonization may be carried out retrospectively for existing monographs or chapters or prospectively for new monographs or chapters.
The PDG pharmacopoeias have a commitment to respecting the agreed working procedures and the associated time deadlines as an essential part of the harmonization procedure.
Harmonization of pharmacopeial documents in the PDG occur based on decisions of the expert bodies of each pharmacopoeia. The PDG works transparently in many ways, including, principally, the public notice and comment procedures of each pharmacopoeia.
Where necessary, meetings of experts including technical teleconference/videoconference meetings are held to identify potential solutions to resolve difficult problems.
Sign-off can occur either electronically, by email, by mail, or during the PDG meeting.
The specific stages of the Pre-PDG and PDG Procedure (Process) involved in harmonization are:
- Pre-PDG
- Stage 1: Preparation of first draft
- Stage 2: Official Inquiry
- Stage 3: Consensus
- Stage 4: Regional adoption and implementation
- Stage 5: Inter-regional acceptance (for chapters previously evaluated by ICH Q4B for Regulatory Interchangeability)
- Revisions, Corrections and Suppressions