Reference drug: what is it?

With the advent of the unified regulatory framework of the EAEU, significant changes have taken place in the classification of medicines. In particular, a category of drugs called "reference" has appeared.

According to Decision No. 78:

"reference medicinal product" is a medicinal product that is used as a reference drug and is a standard by which the properties of a medicinal product are determined (normalized);

Practically, a reference drug is necessary for conducting bioequivalence studies and preparing reviews of the preclinical and clinical part of Module 2 of the dossier in order to subsequently register generic or hybrid drugs.

When choosing a reference drug, the provisions of Decision No. 85 are followed and it is selected according to the following criteria:

1. the original medicinal product, the quality, safety and effectiveness of which were established during registration in the EAEU;
2. an original medicinal product registered in a state where the level of requirements for the regulation of the pharmaceutical market is not lower than the level established in the Union, if paragraph 1 cannot be fulfilled;
3. a generic product registered in each of the EAEU Member States and confirmed its bioequivalence to the original medicinal product (with approval by the Expert Committee of the Commission) if it is impossible to comply with paragraphs 1 and 2;
4. a medicinal product that has experience of use in the territory of one of the member states for at least 25 years (with approval by the Expert Committee on Medicines at the Eurasian Economic Commission) if it is impossible to comply with paragraphs 1-3.

In addition, there is a list of recommendations for choosing a reference drug, available at the link: https://eec.eaeunion.org/comission/department/deptexreg/formirovanie-obshchikh-rynkov/recommendations.php

At the end of July 2024, the list was updated with 24 recommendations.