ICH Culture: Its Maintenance and Development

Area of Science:

• Pharmaceutical regulatory harmonization
• Global health policy
• Drug development standards

Background:

• The European Federation of Pharmaceutical Industries and Associations (EFPIA), Japanese Pharmaceutical Manufacturers Association (JPMA), and Pharmaceutical Research and Manufacturers of America (PhRMA) are founding industry members of the International Council for Harmonisation (ICH).
• These organizations have a 25-year history of contributing to the ICH.
• Anticipated further globalization of the ICH necessitates preserving its established culture and principles.

Purpose of the Study:

• To emphasize the importance of maintaining the ICH culture and its core principles.
• To propose strategies for sustaining and developing the ICH's momentum amidst increasing globalization.
• To ensure continued transparency and objectivity in industry's ICH activities.

Main Methods:

• The study advocates for a two-way approach to sustain ICH culture.
• This includes dialogues among leaders of industry associations (e.g., Industry Executive Council).
• It also involves grassroots activities and engagement with wider stakeholders in global forums (e.g., DIA).

Main Results:

• The proposed approach aims to share common views among industry leaders.
• Grassroots activities and global forums facilitate the dissemination of ICH values, knowledge, and culture worldwide.
• This strategy supports the principles of 'benefit to patients first' and a 'science-based approach.'

Conclusions:

• Valuing the ICH's legacy and maintaining its culture are crucial for future globalization.
• A dual approach of leadership dialogue and broad stakeholder engagement is essential.
• Continued commitment to patient benefit and scientific rigor will ensure the ICH's ongoing success and global impact.