for Japanese

Biologics Committee

The Biologics Committee engages in a wide range of activities, covering treatments that have already been commercialized such as protein-preparations and antibody-based medicines created using genetic recombinants and other techniques, treatments based on next-generation medical technology that can hopefully be commercialized in the future such as products for regenerative medicine as well as nucleic acid-based pharmaceuticals, blood products including blood-related genetically-modified products, and vaccines. Three subcommittees, divided according to product group, are engaged in the following activities in order to improve the technical and regulatory environment for development, manufacturing, supply and safety monitoring.

Blood Product Subcommittee (BPSC): BPSC aims to establish a stable supply process for “Plasma Derived Products” manufactured from human blood and for essential products in medical care, and for any plasma related recombinant products that are manufactured with the world’s most advanced technology. With an eye to the future, the BPSC is also pursuing recommendations and dialogues with the Japanese Government to solve issues such as a lack of blood donors, and a production and supply process for plasma derived products during both normal times and emergencies.

Vaccine Subcommittee: In recent years, innovative overseas vaccines have been approved and come into use in Japan, and a considerable improvement has been achieved in the vaccine gap versus overseas countries. However, many areas still require work, including certain systemic issues such as the continued inability to use certain pediatric vaccines in Japan as well as low rates of vaccination. The subcommittee makes proposals to resolve these issues and works to provide good vaccines more promptly and more broadly in Japanese clinical settings.

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