Refined Training, Project Selection, and Membership Processes Strengthen ICH’s Global Harmonization Efforts

Refined processes for training, project selection and membership are strengthening ICH’s ability to realize in practice the global harmonization objectives of its guideline development efforts, ICH leaders are affirming.

These three prongs of the ICH strategy to further its harmonization goals and how they were reinforced by the 2015 reform of its structure, procedures, and funding were in focus at a session on ICH at the DIA 2018 Global Annual Meeting in Boston in late June.

The session brought together a panel of key members of the ICH management team to assess how the organization’s process is evolving and the challenges and opportunities that are now presenting themselves.  ICH’s biannual meeting had taken place in Kobe, Japan a few weeks before, and the panelists had a chance to weigh in on the developments.

The session began with FDA Center for Drug Evaluation and Research (CDER) Office of Strategic Programs Operations Research Analyst Amanda Roache providing background on ICH’s original formation, the impact of the restructuring that occurred in 2015, its mission of fostering international harmonization, and its current membership.  

Presentations followed by two other FDA representatives on the ICH leadership team, CDER Strategic Initiatives Associate Director Theresa Mullin and CBER Senior International Health Sciences Advisor Michelle Limoli.

Mullin, the current chair of the ICH Management Committee, provided insights on the ICH process for selecting topics for guideline projects and how this process was impacted by the 2015 reforms. She then reviewed some of ICH’s recent efforts and the topics that were endorsed in Japan, explaining how and why they were selected.

Limoli, who serves on ICH’s training subcommittee, explored the development and implementation of ICH training programs. She explained the concerns that are driving the heightened attention on training and what is being done to make the training more supportive of ICH’s goal of consistent, broad-based guideline implementation.

A panel discussion followed, with Roache serving as the moderator. Joining the panel were participants on the ICH management committee and assembly representing Health Canada, Japan’s PMDA, the Pharmaceutical Research and Manufacturers of America (PhRMA), the International Generic and Biosimilar Medicines Association (IGBA), and the Biotechnology Innovation Organization (BIO).   

The panelists provided their perspectives on: ● the generic industry engagement with the ICH process ● the impact of the 2015-16 reforms and the ICH focus going forward ● topic selection ● implementation challenges ● ICH implementation in Asia ● learnings from the ICH training pilot, and ● whether expedited regulatory pathways constitutes a suitable ICH topic.

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