Biosimilars

• ANMAT, Argentina
• ANVISA, Brazil
• COFEPRIS, Mexico
• CPED, Israel
• EAC
• EC, Europe
• EDA, Egypt
• FDA, United States
• GHC
• Health Canada, Canada
• HSA, Singapore
• JFDA, Jordan
• MFDS, Republic of Korea
• MHLW/PMDA, Japan
• MHRA, UK
• NAFDAC, Nigeria
• NRA, Iran
• PAHO/PANDRH
• SAHPRA, South Africa
• SFDA, Saudi Arabia
• Swissmedic, Switzerland
• TFDA, Chinese Taipei
• TGA, Australia
• TITCK, Türkiye
• WHO

Scope: 

• To discuss regulatory challenges and potential topics/areas for harmonization or convergence regarding biosimilars
• To consider how regulatory convergence can be achieved and how regulatory information can be exchanged without compromising confidentiality

• To explore work sharing process with other international bodies and to collaborate in terms of training of international regulators

   

Objectives

• For regulatory convergence of technical requirements for biosimilar products in facilitating the regulatory process
• To support international regulators in developing safe and effective regulatory frameworks for biosimilar products