Procedure for state registration of certain medicines without clinical trials established

A new procedure for the state registration of certain medicines without clinical trials has been officially established, according to a report from the Ministry of Justice.  

On January 17, the "Regulation on the Procedure for State Registration of Certain Medicines Without Clinical Trials" was registered with the Ministry of Justice. This regulation outlines that the decision to register medicines without clinical trials will be made by the Permanent Expert Council, which was established by the Ministry of Health. The council will act on the recommendation of the Pharmacology Committee of the State Institution "Center for the Safety of Pharmaceutical Products."  

Under the new procedure, the state registration of medicinal products without clinical trials and the issuance of a registration certificate will follow the guidelines set by the relevant government resolution.  

Medicinal products eligible for registration without clinical trials include:  
- Medicines that are exempt from compliance with "Good Manufacturing Practice - GMP" studies;  
- Generic medicines and galenic preparations submitted for registration by local manufacturers, whose safety and efficacy have been proven in pre-clinical studies to be at least equivalent to the reference drug;  
- Medicines produced by one manufacturer under different trade names with the same composition.