What are the requirements for conducting a clinical study on humans according to Federal Law No. (8) of 2019 on Medical Products, Pharmacy Profession and Pharmaceutical Establishments, Article (14)?
According to Article (14) of Federal Law No. (8) of 2019, no clinical study or any study involving the bioavailability or bioequivalence of a medical product can be conducted on humans without obtaining prior approval from the Ministry or the relevant Body, as applicable.