Legend:
E = Europe
I = International
J = Japan
U = USA
REGULATORY
ODDG_TF_Building Block Form_E105_European Medicines Agency’s Scientific Advisory Groups (SAGs)Download
ODDG_TF_Building Block Form_E109_Marketing Authorization under Exceptional circumstances (MAUEC)Download
ODDG_TF_Building Block Form_E110_EMA Qualification of novel methodologies for medicine development (EMA-Qualification)Download
ODDG_TF_Building Block Form_E111_Potential for Synergy with Pediatric Regulation (+2 years of Market exclusivity)Download
ODDG_TF_Building Block Form_E114_Certification for advanced therapy medicinal products (ATMPs)Download
ODDG_TF_Building Block Form_E116_EMA Framework for stakeholder’s engagement – patients, academia, healthcare professionalsDownload
ODDG_TF_Building Block Form_E133_Advanced Therapy Medicinal Products (ATMPs) Classification Download
ODDG_TF_Building-Block-Form_J301_Japanese Orphan Drugs/Medical Devices/Regenerative Medical Products Designation (J-ODD)Download
ODDG_TF_Building-Block-Form_J304_Regulatory Science General Consultation and Regulatory Science Strategy Consultation (R&D)Download
ODDG_TF_Building-Block-Form_J305_Consultations on Pharmacogenomics / Biomarkers (As part of PMDA consultations)Download
ODDG_TF_Building-Block-Form_J307_Conditional Early Approval System for Medical Devices (CEASD)Download
ODDG_TF_Building-Block-Form_J308_Conditional and Time-limited Authorization of Regenerative Medical Products (CTARP)Download
ODDG_TF_Building-Block-Form_J310_Study Group on Unapproved and Off-label Drugs of High Medical NeedDownload
ODDG_TF_Building-Block-Form_U203_FDA Expedited Program for serious conditions – Fast Track DesignationDownload
ODDG_TF_Building-Block-Form_U204_FDA Expedited Program for serious conditions – Breakthrough Therapy Designation (FDA-BTD)Download
ODDG_TF_Building-Block-Form_U205_FDA Expedited Program for serious conditions – Accelerated Approval (FDA-AA)Download
ODDG_TF_Building-Block-Form_U206_FDA Expedited Program for serious conditions – Priority Review Designation (FDA-PR)Download
ODDG_TF_Building-Block-Form_U207_FDA Expedited Program for serious conditions – Special Protocol Assessment (FDA-SPA)Download
ODDG_TF_Building-Block-Form_U217_Stakeholders interactions – Professional affairs and Community EngagementDownload