Clinical Research Ethics Committee

Clinical Research Ethics Committee Application Fees

REFERENCE TYPES APPLICATION FEES (Year 2022)
FIRST APPLICATION
Phase I, II, III- Clinical Trial First Application of Pharmaceuticals, Medicinal and Biological Products and Herbal Products (Except for Specialization Theses or Academic Purposes) 7.134.00
Phase IV Pharmaceutical Medicinal and Biological Products and Herbal Products Clinical Trial First Application (Except for Specialization Theses or Academic Purposes) 3,579.00
Initial Application for Observational Drug Studies (Except for Specialization Theses or Academic Purposes) 3,579.00
BY/BE Studies First Application (Except for Specialization Theses or Academic Purposes) 3,579.00
Health Claimed Product / Method Clinical Trial Initial Application (Except for Specialization Theses or Academic Purposes) 7.134.00
APPLICATION FOR IMPORTANT CHANGE
Significant Change Application (Pharmaceutical, Medical, Biological and Herbal Products and Health Claimed Product / Method Clinical Trials, BY/BE Studies and Observational Drug Studies) 2,428,00
APPLICATION FOR CHANGE
Amendment Application (Pharmaceutical, Medical, Biological and Herbal Products and Health Claimed Product / Method Clinical Trials, BY/BE Studies and Observational Drug Studies) 143.00
STORAGE-ARCHIVING SERVICE REFERENCES
Clinical Investigational Product Storage Service Control Application 9,712.00
Clinical Research Documents Archiving Service Control Application 9,712.00
Certificate of Compliance for Storage of Clinical Investigational Product 937.00
Certificate of Conformity for Clinical Research Documentation Archiving Service 937.00
Loss Clinical Investigation Product Storage Compliance Certificate 937.00
Certificate of Conformity for Archiving Service of Lost Clinical Research Documents 937.00
IMPORT APPLICATIONS
Import Application of Investigational Products to be Used in Clinical Trials 654.00
Import Application of Investigational Products (without CE mark) to be used in Medical Device Clinical Trials 654.00
Medical Device Clinical Trial Amendment Application (For Studies Carrying and Not Carrying CE Mark) 143.00
RESEARCHER MEETING APPLICATIONS
Clinical Research Investigator Meeting Applications 283,00