for Japanese

Technical Committee

The Technical Committee works to improve the regulations as well as development and evaluation techniques that affect the innovative pharmaceutical industry and the implementation of those regulations. The aim is to ensure the rapid access by Japanese patients to safe and effective treatments.

Contributions to the development (clinical trials) environment: The Clinical Subcommittee regularly conducts investigations of the clinical trials environment in order to confirm changes in the environment and make recommendations based upon those changes. The Anti-cancer Drug Subcommittee makes proposals focused on the environment for implementing clinical trials of anti-cancer drugs, while also working in coordination with governmental and academic parties to participate in and make contributions through the "forum for the development of medicines to combat malignant tumors" which discusses various issues in the development of anti-cancer drugs.

Contributions to the regulatory affairs environment: Regulatory Affairs Subcommittee, Anti-cancer Drug Subcommittee, other subcommittees, and task force are involved in investigating problem points and conducting interviews to gather opinions and requests regarding related regulations, guidelines and Q&As, as well as newly issued proposals in connection to the above, so as to resolve or make recommendations regarding such matters. The Product Quality subcommittee facilitates the appropriate and efficient implementation of submission and review of new drugs developed outside Japan and LCM of approved drugs manufactured outside Japan.

Contributions to safety and technology: The Safety/PMS Subcommittee contributes to improvements in systems for monitoring the safety of Japanese pharmaceuticals through projects involving the participation of regulatory authorities and other pharmaceutical industry groups. The Pharmacokinetics/Pharmacodynamics Task Force (PK/PD TF) contributes to advance global development through activities including cooperation in Ministry of Health, Labour and Welfare-led investigations into differences between different ethnic groups. The Non-clinical Sub-committee contributes to improved evaluations and proposes new approaches based on the sharing of information, the organization of study meetings, and cooperation in the Pharmaceutical Evaluation Forum.

Contributions to Biological Products: Biological products are diverse but expected as great hope of new and innovative measure of treatments. Among important issues are the future positioning of biosimilars as well as regenerative treatments including genetic treatment. The Biological Products Subcommittee harnesses the experience and track record of EFPIA in Europe in order to evaluate various different issues in regulations and produce recommendations.

Materials for TEC Activities