Guidelines For Preclinical And Clinical Researches On Covid-19 Published

Turkish Medicines and Medical Devices Agency  ("The Agency") has recently published an informative letter related to the procedures prior the clinical researches on Covid-19 vaccines.

Pursuant the Decree Law no. 4, the clinical researches for a candidate vaccine may be initiated only after the approval of the ethical committee of The Agency and the authorisation of The Agency.

The Agency has referred to the reference guideline table called "Relevant WHO documents for SARS-CoV-2 vaccines and other biologicals" of The World Health Organisation and declared that according to the vaccine type, these guidelines mentioned on this reference document of WHO may be used.

The Agency has also informed that the exception on the "Guidelines on the quality, safety and efficacy of Ebola vaccines" will be applicable for vaccines of Covid-19.