Comparison of registration parameters of angiotensin converting enzyme inhibitors and angiotensin II receptor blockers in different countries

Aim. Conduction of quantitative and qualitative analysis of registration parameters of medications of two groups - angiotensin converting enzyme inhibitors and angiotensin II receptor blockers in Russian Federation compared to those of leading drug regulators.

Methods. The whole list of currently existing angiotensin converting enzyme inhibitors and angiotensin II receptor blockers according to international Anatomical Therapeutic Chemical Classification of drugs was analyzed by quantitative and qualitative characteristics in four national drug regulators: State drug register of the Russian Federation, American drug regulator - Food and Drug Administration, European Medicines Agency, and Australian drug regulator - Therapeutic Goods Administration.

Results. It was found that by the number of registered international nonproprietary names and by the number of trade names in the group of angiotensin converting enzyme inhibitors the leading position is taken by State drug registry of the RF, and in the group of angiotensin II receptor blockers Therapeutic Goods Administration is leading. On the territory of Russian Federation among angiotensin converting enzyme inhibitors, lisinopril, captopril, perindopril and enalapril are registered in the highest numbers of trade names, and among angiotensin II receptor blockers - losartan and valsartan. The example of the best practice is presented by European Medicines Agency with the lowest number of registered international nonproprietary and trade names. The qualitative analysis of registration parameters of angiotensin converting enzyme inhibitors and angiotensin II receptor blockers (accepted indications) revealed that in RF the highest number of indications for both angiotensin converting enzyme inhibitors and angiotensin II receptor blockers is accepted compared to those of the leading drug regulators. The example of the best practice by this criterion is presented by the European regulator - European Medicines Agency. Based on the understanding that all international nonproprietary names in every analyzed pharmacological group are medications of the «me too» category, the decrease of the number of registration positions by national regulator and thorough analysis of evidence of effects are recommended when approving indications.

Conclusion. In the official state drug registry of RF compared to three foreign drug regulators, the highest number of international nonproprietary names and trade names of angiotensin converting enzyme inhibitors are presented as well as indications for both angiotensin converting enzyme inhibitors and angiotensin II receptor blockers.