International Harmonization of Pharmacopoeia

Pharmacopoeial Discussion Group (PDG)

• PDG Harmonization Policy
• PDG Working Procedure
• PDG Press Release / News
• PDG Meeting Highlights
• PDG State of Work
• Implementation of PDG harmonized texts into Japanese Pharmacopoeia ( General Chapters | Monographs )

Note: PDG full texts (starting with the December 22, 2020 sign-offs) and sign-off cover sheets are available.

• PDG Implementation Timetable ( General Chapters | Monographs )
• PDG Stage 2 Official Inquiry
• Report of the PDG 30th Anniversary Symposium

Others

International Activities Related to Pharmacopoeia

• Prospective Harmonization (Montelukast Sodium) Pilot Project (2014)
• Prospective Harmonization (Dapagliflozin Propylene Glycol Hydrate and Dapagliflozin Propylene Glycol Tablets) Press Release (October 2023)