Implementation Structure and Active Task Forces
With a mission to “deliver innovative and highly beneficial pharmaceuticals more quickly to patients, healthcare professionals, and people around the world,” the Drug Evaluation Committee operates by establishing specialized teams (ETs) and task forces (TFs) focused on specific topics to address various challenges in pharmaceutical development.
You can view details on each activity in the materials below.
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Drug Evaluation Committee
We oversee the specialized teams and task forces under the committee, examine technical and regulatory issues related to pharmaceutical development, and conduct policy advocacy and awareness-raising activities.
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List of Expert Teams/Task Forces
View a list of active specialized teams and task forces under the committee.
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Committee Operations
To improve the efficiency and transparency of the committee’s activities, this group examines and implements measures regarding document management and information dissemination. (TFG 10)
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Nonclinical
This team examines technical and regulatory matters related to nonclinical aspects of drug development and engages in policy advocacy and public awareness activities. (Specialized U/TFG 1)
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Clinical
We examine technical and regulatory aspects of pharmaceutical development—from development planning and clinical trials through to marketing authorization applications and post-marketing activities—and make policy recommendations and conduct awareness-raising activities. (Specialized U/TFG 2)
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Pharmacovigilance & Communication
We will examine issues related to safety from pharmaceutical development through post-marketing, and make policy recommendations and conduct awareness-raising activities. (Specialized U/TFG 3)
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Data & Digital Innovation
Examine technical and regulatory matters related to specialized fields such as data science and digital information, and make policy recommendations and conduct awareness-raising activities. (Specialized U/TFG 4)
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GCP Renovation
We will promote clinical trials and coordinate cross-cutting measures related to the regulatory framework, implement GCP Renovation, and disseminate consistent information. (TFG 5)
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Promoting the Use of Medical Information Databases
To promote the utilization of medical information databases, we will conduct cross-cutting reviews of related measures and make recommendations regarding the identification of institutional and operational challenges and their improvement. (TFG 6)
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Review Working Group / Investigation Working Group
We will comprehensively aggregate information and organize key issues within the framework of discussions between government and industry regarding the optimal regulatory environment, and we will examine and implement a system that enables the industry to make policy recommendations. (TFG 7)
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Japan Pharmaceutical Manufacturers Association Working Group
To promote the WT activities conducted in collaboration with the Japan Pharmaceutical Manufacturers Association’s Safety Committee, we will share the status of these activities, focusing on participating members. (TFG 8)
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Patient and Public Involvement & Engagement
To promote PPI/E activities, we will share the status of initiatives and identify challenges, thereby strengthening collaboration with stakeholders and fostering mutual understanding. (TFG 9)