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.
Further, the following guidelines of WHO and ICH are advised for references for preclinical and clinical researches:
- ICH M3(R2): Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals, 2009.
- WHO Guidelines on nonclinical evaluation of vaccines (WHO Technical Report Series, No. 927, 2005)
- WHO Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines (WHO Technical Report Series, No. 987, Annex 2, 2013)
- WHO Guidelines on clinical evaluation of vaccines: regulatory expectations (WHO Technical Report Series 1004, Annex 9, 2016)
Finally, The Agency has also published a table of requirements for viral vaccine candidates to proceed with the clinical researches to guide the research groups.