{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T17:41:06Z","timestamp":1776361266837,"version":"3.51.2"},"reference-count":35,"publisher":"Elsevier BV","issue":"3","license":[{"start":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:00:00Z","timestamp":1777593600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T00:00:00Z","timestamp":1777593600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["clinicalkey.fr","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Annales Pharmaceutiques Fran\u00e7aises"],"published-print":{"date-parts":[[2026,5]]},"DOI":"10.1016\/j.pharma.2025.12.011","type":"journal-article","created":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T16:06:35Z","timestamp":1766073995000},"page":"442-453","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative study of regulatory frameworks for medicinal products in Eurasian Economic Union and European Union"],"prefix":"10.1016","volume":"84","author":[{"given":"Keerthana","family":"CP","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3662-4635","authenticated-orcid":false,"given":"Sanjay","family":"Sharma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.pharma.2025.12.011_bib0180","unstructured":"Eurasian Economic Union n.d. http:\/\/www.eaeunion.org\/?lang=en#about-countries [accessed July 2, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0185","series-title":"Agreement on common principles and rules of circulation of medicinal products within the Eurasian Economic Union","year":"2014"},{"key":"10.1016\/j.pharma.2025.12.011_bib0190","series-title":"The rules of marketing authorization and assessment of medicinal products for human use","year":"2016"},{"key":"10.1016\/j.pharma.2025.12.011_bib0195","unstructured":"European Union. Facts and figures on the European Union n.d. https:\/\/european-union.europa.eu\/principles-countries-history\/facts-and-figures-european-union_en#:\u223c:text=Population%3A%20more%20than%20448%20million,to%20420%20million%20by%202100 [accessed November 12, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0200","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1002\/tie.10014","article-title":"Evolution of pharmaceutical regulations and their consequences in the European Union and the United States","volume":"44","author":"Tancer","year":"2002","journal-title":"Thunderbird Int Bus Rev"},{"key":"10.1016\/j.pharma.2025.12.011_bib0205","series-title":"Directive 2001\/83\/EC of the European Parliament on the community code relating to medicinal products for human use","year":"2001"},{"key":"10.1016\/j.pharma.2025.12.011_bib0210","series-title":"Regulation (EC) No. 726\/2004 of the European Parliament \u2013\u00a0laying down community procedure for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency","year":"2004"},{"key":"10.1016\/j.pharma.2025.12.011_bib0215","series-title":"Market authorization process for medicinal products in Eurasian Economic Union Council","author":"Pawar","year":"2023"},{"key":"10.1016\/j.pharma.2025.12.011_bib0220","unstructured":"Zakharochkina ER, Rayisyan MG, Bekhorashvili N, Garankina RY, Ryajemov VV, Simonyan M. Uniform rules for registering medicinal products in the Eurasian Economic Union. n.d."},{"key":"10.1016\/j.pharma.2025.12.011_bib0225","series-title":"Rules of procedure of the Expert Committee for Medicinal Products","year":"2016"},{"key":"10.1016\/j.pharma.2025.12.011_bib0230","series-title":"Volume 2A Procedures for marketing authorisation chapter 2 mutual recognition","year":"2007"},{"key":"10.1016\/j.pharma.2025.12.011_bib0235","series-title":"Requirements for the labelling of medicinal products for human use and veterinary medicinal products (decision No. 76)","year":"2016"},{"key":"10.1016\/j.pharma.2025.12.011_bib0240","series-title":"Guideline on the packaging information of medicinal products for human use authorized by the union","year":"2023"},{"key":"10.1016\/j.pharma.2025.12.011_bib0245","series-title":"Packaging \u201cblue-box\u201d requirements and additional information on labelling\/package leaflet for products authorised via national, mutual recognition, decentralised or centralised procedures","year":"2014"},{"key":"10.1016\/j.pharma.2025.12.011_bib0250","unstructured":"Eurasian Economic Commission. Decision 79 \u2013\u00a0Good Clinical Practice 2016."},{"key":"10.1016\/j.pharma.2025.12.011_bib0255","doi-asserted-by":"crossref","first-page":"66","DOI":"10.56012\/odis4682","article-title":"Clinical trials in the Eurasian Economic Union","volume":"32","author":"Radkova","year":"2023","journal-title":"Med Writ Eur Med Writ Assoc"},{"key":"10.1016\/j.pharma.2025.12.011_bib0260","series-title":"Rules for conducting bioequivalence studies of medicinal products within the framework of the EAEU (decision No. 85)","year":"2016"},{"key":"10.1016\/j.pharma.2025.12.011_bib0265","series-title":"Guidelines on general issues of clinical trials (recommendation No. 11)","year":"2018"},{"key":"10.1016\/j.pharma.2025.12.011_bib0270","unstructured":"Clinical Trials Regulation | European Medicines Agency (EMA). n.d. https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/clinical-trials-human-medicines\/clinical-trials-regulation [accessed November 17, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0275","unstructured":"European Medicines Agency. CTIS evaluation timelines 2024. https:\/\/www.ema.europa.eu\/en\/documents\/other\/clinical-trial-information-system-ctis-evaluation-timelines_en.pdf [accessed November 17, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0280","unstructured":"New part of EAEU Pharmacopoeia approved. n.d. https:\/\/eec.eaeunion.org\/en\/news\/utverzhdena-novaya-chast-farmakopei-eaes\/ [accessed December 6, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0285","series-title":"Concept of harmonization of Pharmacopoeia of EAEU","year":"2015"},{"key":"10.1016\/j.pharma.2025.12.011_bib0290","unstructured":"Preliminary discussion of draft approved pharmacopoeia monographs. n.d. https:\/\/eec.eaeunion.org\/comission\/department\/deptexreg\/formirovanie-obshchikh-rynkov\/pharmacopoeia\/pharmacopoeia_PO.php [accessed December 7, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0295","series-title":"Rules of good pharmacovigilance practice (decision No. 87)","year":"2016"},{"key":"10.1016\/j.pharma.2025.12.011_bib0300","series-title":"The approval of pharmaceutical inspection rules","year":"2016"},{"key":"10.1016\/j.pharma.2025.12.011_bib0305","unstructured":"Eurasian Economic Commission. Integrated information system of the Eurasian Economic Union (integrated system). Portal of General Information Resources and Open Data. n.d. https:\/\/portal.eaeunion.org\/en-us\/public\/tech-iis.aspx [accessed November 17, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0310","unstructured":"EudraLex \u2013\u00a0Volume 4\u00a0\u2013 European Commission. n.d. https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en#introduction [accessed December 8, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0315","series-title":"Requirements for the study of stability of medicinal products and pharmaceutical substances","year":"2018"},{"key":"10.1016\/j.pharma.2025.12.011_bib0320","series-title":"Stability testing of active pharmaceutical ingredients and finished pharmaceutical products stability conditions for WHO member States by region","year":"2021"},{"key":"10.1016\/j.pharma.2025.12.011_bib0325","series-title":"Guideline for stability testing: stability testing of existing active substances and related finished products","year":"2003"},{"key":"10.1016\/j.pharma.2025.12.011_bib0330","unstructured":"Active substance master file procedure \u2013\u00a0Scientific guideline | European Medicines Agency (EMA). n.d. https:\/\/www.ema.europa.eu\/en\/active-substance-master-file-procedure-scientific-guideline#current-version-final-7863 [accessed December 10, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0335","unstructured":"Tax Code of the Russian Federation Part II. n.d."},{"key":"10.1016\/j.pharma.2025.12.011_bib0340","unstructured":"Scientific Center of Drug and Medical Technologies Expertise. State duty rates and paid services. n.d. https:\/\/www.pharm.am\/index.php\/en\/bank-requisites [accessed December 10, 2024]."},{"key":"10.1016\/j.pharma.2025.12.011_bib0345","series-title":"On state registration of strategically important medicinal products","year":"2021"},{"key":"10.1016\/j.pharma.2025.12.011_bib0350","series-title":"Regulation (EU) 2024\/568 \u2013\u00a0fees and charges payable to the European Medicines Agency","year":"2024"}],"container-title":["Annales Pharmaceutiques Fran\u00e7aises"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003450925002202?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003450925002202?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T16:44:37Z","timestamp":1776357877000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0003450925002202"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5]]},"references-count":35,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,5]]}},"alternative-id":["S0003450925002202"],"URL":"https:\/\/doi.org\/10.1016\/j.pharma.2025.12.011","relation":{},"ISSN":["0003-4509"],"issn-type":[{"value":"0003-4509","type":"print"}],"subject":[],"published":{"date-parts":[[2026,5]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Comparative study of regulatory frameworks for medicinal products in Eurasian Economic Union and European Union","name":"articletitle","label":"Article Title"},{"value":"Annales Pharmaceutiques Fran\u00e7aises","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.pharma.2025.12.011","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2025 Acad\u00e9mie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}]}}