The adopted Guideline has been approved for the use by the authorized bodies of the EAEU member states.
The Guideline applies to dosage forms in which the modification of the rate and (or) the place of release of the active ingredient (active substances) in a definite manner is compared with the standard release dosage forms.
Such modification may be carried out to prolong the therapeutic activity of the drug, reduce the toxic effect, protect the active ingredient from degradation due to a low pH, release the active ingredient from the dosage form in a predetermined segment of the gastrointestinal tract for local action or at defined time points, and for other purposes.
The Guidance is to be used during planning and conduction of scientific research on pharmaceutical development, as well as in the preparation of registration dossiers.
The Guideline is recommended to be used after 6 months from the date of publication of this Recommendation No. 2 of 16 January 2018 on the official site of the EAEU for the purposes of planning bioequivalence studies and for the purposes of making changes to the registration dossiers of modified-release drugs intended for oral administration.