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Rules for conducting bioequivalence studies of EAEU medicines updated

Rules for conducting bioequivalence studies of EAEU medicines updated

9/4/2020

On September 4, the Eurasian Economic Commission (EEC) Council approved amendments to the rules for conducting bioequivalence studies of pharmaceuticals. They have been supplemented by two new annexes enabling to establish unified approaches to confirm equal efficiency and interchangeability of such groups of pharmaceuticals as ointments, gels and creams for topical application as well as tablets and capsules of extended delayed action. 

 

Previously, no peculiarities of dosage forms were taken into account when studying equivalence of these pharmaceutical groups. The amendments will enable identifying ineffective or non-equivalent pharmaceuticals at their development phase and preventing their release into circulation. 

 

The proposed approaches to establishing equal efficiency and safety of "copied" medicines will also reduce manufacturers' cost on performing full-scale clinical trials, replacing them with studies on small groups of volunteers or modeling such studies. This will eliminate the need for duplicating studies in each of the EAEU States and possible non-recognition of research results within the Union.​