12.04.2024 (Обновлено: 17.04.2024 10:42)

Rules for conducting bioequivalence studies of medicinal products amended

On April 12, the Eurasian Economic Commission's Council amended the Rules for conducting bioequivalence studies of pharmaceuticals within the Eurasian Economic Union.

The amendments concern two procedures – the selection of a reference preparation in conducting bioequivalence studies of medicinal products and the procedure for replacing human bioequivalence studies with model laboratory studies (conducting a biowaiver).

The procedure for selecting reference medicinal products includes the possibility of selecting additional alternatives. As Valentin Tataritsky explained to the EEC Council members, "the amendment is due to the difficulties that arise with the supply of original pharmaceuticals, selected as reference ones, to the Union's customs territory".

These options make it easier to procure pharmaceuticals in third countries as well as allow for the wider use of copied pharmaceuticals (generics) as reference medicines.

Changes in the requirements to the biowaiver procedure include the possibility of using this procedure for prodrugs – medicines that contain initially inactive molecules, and their transformation into medicines occurs in the human body. There is another possibility - using this procedure for 3rd class medicines (poorly soluble but well absorbed medicines) without obtaining the approval of the Expert Committee on Medicines.

The amendments are in line with similar regulations used in the European region, Asia and America countries, as well as approaches used by the World Health Organization to allow the circulation of generics.