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Regulatory Science/The Science Board/Standard Development

Outline of The Science Board

PMDA established the Science Board on May 14th 2012, as a high-level consultative body which discusses scientific aspects of pharmaceuticals, medical devices and regenerative medical products review. The purposes of the Science Board are, advancing regulatory science and evaluate products with advanced science and technology in appropriate manner by enhancing cooperation and communication with academia and medical institutions, based on PMDA's philosophy to deliver safe and effective drugs, medical devices and regenerative medical products to the people and further promotion of medical innovations.

 

About The Science Board

The Science Bord consists of parental meetings and sub committees. The Science Board, based on the discussions and deliberations of the Science Board Subcommittees, discusses the following

  • Recommendation of policies for products applying advanced science and technology
  • Recommendations on the preparation of guidelines, guidance, etc.
  • Recommendations on other measures to improve the scientific aspects of review and other operations

For more details, please visit  the Science Board site.

 

About Subcommittees

The Science Board Subcommittees ("Subcommittees") were established for PMDA staff members to discuss issues they are facing with the Subcommittees' members who are the front-line researchers of their specialized fields.
For more details, please visit the Subcommittees site.

 

Standards for meeting materials and minutes

The Science Board and the Subcommittee meetings are independent of the PMDA review process, but because information about individual products may be discussed, the meetings are held in closed session. All meeting materials and minutes will be disclosed in Japanese (except for confidential information).
 

Member List

The 6th Term Science Board Member List (As of June 1, 2022)
For a list of the Subcommittee members, please refer to the Subcommittees site.