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Provisions of the National and EEU Legislation on Pharmacopoeia: Updating and Prospects of Development

  • STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL
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Pharmaceutical Chemistry Journal Aims and scope

Key provisions stated by statutory and regulatory enactments of the Russian Federation and Eurasian Economic Union (EEU) that determine the legal basis for publication of the State Pharmacopoeia and the Pharmacopoeia of the EEU are reviewed. Domestic legislation and regulatory enactments of the EEU were compared and analyzed taking into account the approaches used in publication of the world’s leading pharmacopoeias. Promising directions in the development of national legislation were highlighted based on global trends toward harmonization of quality requirements of medicines. The present study demonstrated the need to amend the terms mentioned in national regulations, improve the structure of the State Pharmacopoeia of the Russian Federation, update some of the requirements indicated in national regulatory enactments, and elaborate new requirements to provide transparency for the process of developing pharmacopoeial requirements for the subjects of circulation of medicinal products. Information and analytical analysis revealed promising areas for the development of domestic legislation in the field of pharmacopoeial requirements. Public discussion will improve the efficiency of establishing state requirements for drug quality and amending existing regulatory acts. If necessary, new legislative acts regulating the details and discrepancies of this process will be developed and approved.

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Notes

  1. Agreement on Common Principles and Rules of Circulation of Medicinal Products Within the Eurasian Economic Union, signed on Dec. 23, 2014, in Moscow.

    Federal Law No. 5-FZ of the Russian Federation of Jan. 31, 2016, “On Ratification of the Agreement on Common Principles and Rules of Circulation of Medicinal Products Within the Eurasian Economic Union.”

  2. Decision of the Council of the Eurasian Economic Commission No. 100 of Aug. 11, 2020, “On the Pharmacopoeia of the Eurasian Economic Union.”

  3. Federal Law No. 61-FZ of Apr. 12, 2010 “On circulation of medicines.”

  4. State Pharmacopoeia of the Russian Federation, XIIIth Ed., Moscow (2015).

  5. Decision No. 119 of the Council of the Eurasian Economic Commission of Sept. 22, 2015 “On the Concept of the Harmonization of the Pharmacopoeia of the Eurasian Economic Union Member States.”

  6. State Pharmacopoeia of the Russian Federation, XIVth Ed., Moscow (2018).

  7. Order No. 749 of the Ministry of Health of the Russian Federation of Oct. 31, 2018 “On approval of general pharmacopoeia monographs and pharmacopoeia monographs and declaring inactive several orders of the Ministry of Health and Medical Industry of Russia, Ministry of Health and Social Development of Russia, and Ministry of Health of Russia.”

  8. Ministry of Health of the Russian Federation Order No. 185 of Mar. 29, 2019 “On approval of a general pharmacopoeia monograph and pharmacopoeia monograph”;Ministry of Health of the Russian Federation Order No. 352 of Apr. 21, 2020 “On approval of a general pharmacopoeia monograph and amendment in appendix No. 1 of Ministry of Health of the Russian Federation Order No. 749 of Oct. 31, 2018 ”On approval of general pharmacopoeia monographs and pharmacopoeia monographs and declaring inactive several orders of the Ministry of Health and Medical Industry of Russia, Ministry of Health and Social Development of Russia, and Ministry of Health of Russia";

    Ministry of Health of the Russian Federation order No. 751 of Jul. 28, 2020 “On approval of a pharmacopoeia monograph and amendment in appendix No. 2 of Ministry of Health of the Russian Federation Order No. 749 of Oct. 31, 2018 ”On approval of general pharmacopoeia monographs and pharmacopoeia monographs and declaring inactive several orders of the Ministry of Health and Medical Industry of Russia, Ministry of Health and Social Development of Russia, and Ministry of Health of Russia";

    Ministry of Health of the Russian Federation Order No. 1305 of Dec. 8, 2020 “On approval of pharmacopoeia monograph PM.2.1.0221.20 ”Absolute ethanol. Ethanolum anhydricum";

    Ministry of Health of the Russian Federation Order No. 1332 of Dec. 15, 2020 “On approval of general pharmacopoeia monographs and pharmacopoeia monographs”;

    Ministry of Health of the Russian Federation Order No. 133 of Feb. 25, 2021 “On approval of general pharmacopoeia monographs and pharmacopoeia monographs and amendment to Ministry of Health of the Russian Federation Order No. 749 of Oct. 31, 2018 ”On approval of general pharmacopoeia monographs and pharmacopoeia monographs and declaring inactive several orders of the Ministry of Health and Medical Industry of Russia, Ministry of Health and Social Development of Russia, and Ministry of Health of Russia."

  9. Ministry of Health of the Russian Federation Order No. 787 of Jul. 19, 2021 “On approval of a pharmacopoeia monograph”;Ministry of Health of the Russian Federation Order No. 246 of Apr. 11, 2022 “On approval of general pharmacopoeia monographs and pharmacopoeia monographs.”

  10. GPM.1.1.0001.18 Rules for use of pharmacopoeia monographs. SP RF XIVth Ed., Vol. 1, Moscow (2018);GPM.1.1.0002.15 International system of units (SI) used in pharmacopoeia. SP RF, XIVth Ed., Vol. 1, Moscow (2018);

    GPM.1.1.0010.18 Storage of drugs. SP RF, XIVth ed., Vol. 1, Moscow (2018).

  11. European Pharmacopoeia, 11th Ed., EDQM, Strasbourg (2022).

  12. United State Pharmacopeia, USP 43-NF 38, Rockville, MD (2019).

  13. Ministry of Health and Social Development of Russia Order No. 756n of Aug. 26, 2010 “On approval of the order of development of general pharmacopoeia monographs and pharmacopoeia monographs and their inclusion in the state pharmacopoeia and placement on the official internet site of data on the state pharmacopoeia.”

  14. Ministry of Agriculture of Russia Order No. 4 of Jan. 10, 2018 “On approval of the order for compiling a registration dossier for a drug for veterinary use and requirements for documents in it and the order for submitting documents forming the registration dossier for a drug for medical use for the purpose of state registration.”

  15. 1.1. General Statements. Pharmacopoeia of the Eurasian Economic Union. GPM2.1.4.18. Free formaldehyde. Pharmacopoeia of the Eurasian Economic Union.

  16. Ministry of Health of Russia Order No. 857 of Nov. 19, 2013 “On the Council of the Ministry of Health of the Russian Federation on the State Pharmacopoeia.”

  17. Federal Law No. 429-FZ of Dec. 22, 2014 “On amendments to Federal Law ‘On circulation of medicines’.”

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ACKNOWLEDGMENTS

The work was performed in the framework of a state task for SCEEMP, Ministry of Health of Russia, No. 056-00001-22-00 for applied scientific research (state acct. No. NIR 121021800098-4).

CONFLICT OF INTEREST

We declare no conflict of interest requiring disclosure in this article.

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  1. Scientific Centre for Expert Evaluation of Medicinal Products, 8/2 Petrovskii Blvd, Moscow, 127051, Russia

    A. V. Yarutkin & V. I. Bagirova

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  1. A. V. Yarutkin
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  2. V. I. Bagirova
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Correspondence to A. V. Yarutkin.

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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 56, No. 10, pp. 54 – 60, October, 2022.

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Yarutkin, A.V., Bagirova, V.I. Provisions of the National and EEU Legislation on Pharmacopoeia: Updating and Prospects of Development. Pharm Chem J 56, 1400–1406 (2023). https://doi.org/10.1007/s11094-023-02804-5

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