Guidance on waiver of in vivo bioequivalence requirements

By EFDAJuly 14, 2021

Guidance on waiver of in vivo bioequivalence requirements

Guideline on variation applications to registered medicines

By EFDAJuly 14, 2021

Guideline on variation applications to registered medicines

Guideline for Registration of Antiseptics and Disinfectants

By EFDAMarch 6, 2021

Guideline for Registration of Antiseptics and Disinfectants

Guideline for COVID-19 Vaccine donation

By EFDAFebruary 15, 2021

Guideline for COVID-19 Vaccine donation      

Guidance for Emergency Use Authorization of COVID-19 Vaccine

By EFDAJanuary 29, 2021

Guidance for Emergency Use Authorization of COVID-19 Vaccine  

Guideline for Conditional Approval of Medicines

By EFDAJanuary 29, 2021

Guideline for Conditional Approval of Medicines

Guideline for Conditional approval of medicines 2020

By EFDADecember 16, 2020

Guideline for Conditional approval of medicines 2020

Traditional Medicine Clinical Trial guidance 2020

By EFDANovember 9, 2020

Traditional Medicine Clinical Trial guidance 2020    

Supplementary guideline for Clinical trial Authorization 2020

By EFDANovember 9, 2020

Supplementary guideline for Clinical trial Authorization 2020    

Guideline for Registration of oral care skin care products with therapeutic claim

By EFDAOctober 9, 2020

Guideline for Registration of oral care skin care products with therapeutic claim