时事通讯 "Life Science(2025年12月)发布。

Contents

1. Review of the Patent Linkage System: Pilot Introduction of the Expert Committee System
1.1 Overview of Patent Linkage and the Review of the System
1.2 Outline of the Procedures
1.3 Status of the Experts’ Written Opinions
2. Promulgation of Cabinet Order to Amend Related Ministerial Ordinances in Connection with the Enforcement of the Amended PMD Act
2.1 Provisions to Clarify the Use of Real-World Data for Safety Measures
2.2 Conditional Approval for Pharmaceuticals, etc. for Rare and Serious Diseases
2.3 Promotion of the Formulation of Development Plans to Address Drug Loss for Pediatric Pharmaceuticals
2.4 Review of Requirements for Manufacturing Supervisors, etc. for Pharmaceutical Manufacturing Managers
2.5 Revision of Provisions on Methods of Information Provision and Sales of Guidance-Required Drugs, etc.
2.6 Development of Provisions on Information Provision, etc. at the Time of Sale of Designated Abuse-Prevention Drugs