DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of April 12, 2024 No. 30

About modification of Rules of carrying out researches of bioequivalence of medicines within the Eurasian Economic Union

According to Item 2 of Article 4 and article 6 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and Item 86 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission DECIDED:

1. Bring in the Rules of carrying out researches of bioequivalence of medicines within the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 85, of change according to appendix.

2. This Decision becomes effective after 30 calendar days from the date of its official publication.

Members of council of the Eurasian economic commission:

Appendix

to the Decision of Council of the Eurasian economic commission of April 12, 2024 No. 30

The changes made to rules of carrying out researches of bioequivalence of medicines within the Eurasian Economic Union

1. In the text of Item 10 of the word "under the Commission" to exclude.

2. State Item 18 in the following edition:

"18. In case of the choice of reference medicine proceed from the following sequence:

a) original medicine which safety, efficiency and quality were established in case of registration in the Union, and also registered according to the legislation of state members ("the original medicine registered in the Union");

b) the original medicine registered in the countries of the region of the International council on harmonization of technical requirements to medicines for medical application (ICH), or in case of reasons for its absence in the address in the pharmaceutical market of the countries of the region of ICH or impossibility of its acquisition reproduced (or hybrid) the medicine registered at least in one of state members and which confirmed the bioequivalence to original medicine (in case of approval of the choice of the reproduced medicine by Expert committee), in case of impossibility of accomplishment of the subitem "an" of this Item;

c) the medicines approved by Expert committee (the list of decisions is posted on the official site of the Union), in case of impossibility of accomplishment of subitems "an" and "b" of this Item;

d) the medicine having experience of application in the territory of at least one of state members at least 20 years (in case of approval by Expert committee), in case of impossibility of accomplishment of subitems "an" - "in" this Item;

e) the combined medicine considered and approved by Expert committee in case of impossibility of accomplishment of subitems "a" - this Item.

Expert committee the choice as the reference combined medicine containing the known active ingredients and registered at least in one of state members in case of the limited program of its studying which is not allowing to recognize originality, can be made taking into account assessment of duration of medical application of medicine and justification of creation of the fixed combination, in case of impossibility of accomplishment of subitems "a" - "" of this Item.

In case of impossibility to recognize medicine reference because of irrationality of combination, unproven efficiency and safety for development of new medicine carrying out the program of preclinical and clinical trials is offered, to the corresponding development of new combinations, according to acts of bodies of the Union in the field of drug circulation.".

3. In Item 104 of the word "state members of the Union and (or) Expert committee on medicines under the Eurasian economic commission" shall be replaced with words "state members and (or) Expert committee".

4. State appendix No. 4 in the following edition:

"Appendix No. 4

to Rules of carrying out researches of bioequivalence of medicines within the Eurasian Economic Union

Requirements to the bioveyver based on biopharmaceutical classification system

I. General provisions

1. Two medicines containing identical active ingredient (active ingredients) are considered bioequivalent if their bioavailability (speed and extent of absorption of active ingredient) after application in the same molar dose keeps within predefined acceptable borders. Such borders are established for ensuring comparable action of in vivo of the researched medicine (comparability on its safety and efficiency to original (reference) medicine). For assessment of speed and extent of absorption of active ingredient in researches of bioequivalence in vivo the basic pharmacokinetic AUC and Cmax parameters are used.

2. The approach based on application of biopharmaceutical classification system (further - BKS) in case of bioveyver, is directed to reducing need for carrying out researches of bioequivalence of in vivo (can serve as substitute research for assessment of bioequivalence of in vivo). It is allowed not to conduct researches of bioequivalence in vivo if the assumption of equivalence of action of in vivo is proved by means of the satisfactory data in vitro. BKS divides active ingredients into four classes:

class I: good solubility, good penetration;

class II: bad solubility, good penetration;

class III: good solubility, bad penetration;

class IV: bad solubility, bad penetration.

3. These Requirements contain instructions for establishment of class BKS for active ingredient and application to it of the bioveyver based on BKS when replacing researches of bioequivalence of in vivo of medicines. The principles of the bioveyver based on BKS are applicable also for research purposes of bioequivalence of dosage forms of the medicines which are not specified in these Requirements provided that the specified principles are evidence-based.

II. Criteria of application of the bioveyver based on BKS

4. Bioveyver based on BKS is used for reasons for bioequivalence of in vivo. This procedure is applied to carrying out mutual comparison of the pharmaceutical products used during the period since clinical development of medicine before release of its industrial series, assessment of post-registration changes and the registration application as the reproduced medicine.

5. Bioveyver based on BKS is applied only to firm dosage forms to intake or to suspensions with the immediate release intended for delivery of active ingredient in system blood-groove. Concerning the medicines having narrow therapeutic index use of the bioveyver based on BKS for replacement of researches of bioequivalence of in vivo is not allowed. The bioveyver based on BKS is applied to combination of the fixed doses of medicines if all active ingredients containing in such combined medicine answer the criteria formulated in subsections 2 and 3 of the Section III of these Requirements.

6. Bioveyver based on BKS is applied to medicines if active ingredient (substances) has good solubility and good penetration (class I on BKS) or good solubility and bad penetration (class III on BKS).

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