Certain medications will be approved without undergoing clinical trials.

In accordance with the new regulatory act, the following medications will be registered without clinical trials:

• medications that do not require verification of compliance with "Good Manufacturing Practice - GMP" and may be included in the list without clinical trials.
• Some generics and galenic preparations developed by local manufacturers, whose safety and efficacy are comparable to reference drugs, as demonstrated in experimental studies.
• Drugs produced by one manufacturer under different brand names but having the same composition. At least one of these medications must be registered based on positive clinical trials.
• Generic medications with a single active ingredient for oral use, which have proven their equivalence to the reference drug through the "bio waiver" method.
• Medications produced in countries that are part of the European Union and EAEU with a single active ingredient (monopreparations), which have been safe and effective for over 20 years and can be used both orally and parenterally (excluding insulin and its analogs, as well as biosimilars).

The decision to register such medications without clinical trials is made based on the recommendations of the Pharmacology Committee and the permanent Expert Council of the Ministry of Health.