2025-05-14-世界卫生组织-15th_International_Meeting_of_the_World_Pharmacopoeias_27页_611kb

Fifteenth International Meeting of World Pharmacopoeias (IMWP) - 2025

Event Overview

• Held in New Delhi, India, February 6–7, 2025, hosted by the Indian Pharmacopoeia Commission (IPC) in collaboration with WHO.
• 38 participants representing 14 pharmacopoeias attended; European Pharmacopoeia represented 28 pharmacopoeias.
• Featured a stakeholder event on February 5, 2025.

Key Recommendations from 14th IMWP

• Developed and agreed to actions for future pharmacopoeial alignment.
• Initiated a survey for information sharing, drafted an IMWP charter, and established a work program for communication expectations.
• Created principles for environmental sustainability and advocacy.
• Kept specific monographs open for reference until reference substances deplete.

Deep Dive: Impurities

• Participants focused on shared priorities for impurity control, aligning with ICH guidance (Q3A–Q3D).
• Discussed challenges like transition to elemental impurity testing, need for grace periods, and implementation gaps.
• Noted progress in ICH Q6 modernization.

IMWP Charter Development

• Launched initiative to draft a charter defining mission, objectives, and tools.
• Current draft under review raised questions on scope and inclusivity.
• British Pharmacopoeia leads, with action points for distribution, revisions, and adoption.

PDG Updates

• Affirmation of expanded membership (notably IPC as new member) and text sharing processes.
• Work program includes harmonizing general chapters and excipient monographs.
• Action points for improving work plan transparency and dissemination.

Environmental Sustainability

• Joint initiative to agree sustainability principles and develop a white paper.
• Draft principles focus on waste reduction, animal testing reduction, and safety protections.
• Action points for revising scope, ensuring voluntary participation, and drafting a living document.

Future IMWPs

• Brazil offered to host the sixteenth IMWP in 2026 for centennial celebrations.
• Seventh IMWP hosted by EDQM.
• Standing agenda items include continuing deep-dive sessions and communications initiatives.