The Ministry of Justice has registered the Regulation “On the Procedure for State Registration of Certain Medicinal Products Without Clinical Trials” (registration number 3600 of January 17, 2025).
According to the Regulation, the decision to register such medicines is made by a permanent expert council under the Ministry of Health based on the recommendations of the Center for Pharmaceutical Product Safety.
The registration procedure and the issuance of registration certificates are carried out in accordance with the procedure established by the governmental resolution.
The following categories of medicinal products may be registered without clinical trials
– medicinal products included in the list for which it is not necessary to conduct studies for compliance with GMP (Good Manufacturing Practice) requirements
– generics and galenic drugs of local manufacturers, the safety and efficacy of which have been proven in preclinical studies and are not inferior to reference drugs;
– drugs with the same composition manufactured by the same company under different trade names.
We remind that the pharmaceutical market of Uzbekistan is one of the largest for Ukraine.
