The 7 references with contexts in paper K. Koshechkin A., E. Rychikhina M., К. Кошечкин А., Е. Рычихина М. (2018) “Применение информационных технологий для управления фармацевтическими данными // Information technologies as a tool of pharmaceutical data management” / spz:neicon:vedomostincesmp:y:2017:i:2:p:122-125

1
Treaty on the Eurasian Economic Union, Astana, May 29, 2014. Available from: https://goo.gl/lKMyOl (in Russian).
Total in-text references: 1
  1. In-text reference with the coordinate start=2190
    Prefix
    Ñîîòâåòñòâåííî, ñóùåñòâóþò íåîñïîðèìûå äîâîäû â ïîëüçó îðãàíèçàöèè ýôôåêòèâíîãî ìåæäóíàðîäíîãî ñîòðóäíè÷åñòâà â ñôåðå çäðàâîîõðàíåíèÿ, è òàêîå ñîòðóäíè÷åñòâî ÿâëÿåòñÿ íåîáõîäèìîé îñíîâîé óñòîé÷èâîãî ðàçâèòèÿ.  ñîîòâåòñòâèè ñ Äîãîâîðîì î Åâðàçèéñêîì ýêîíîìè÷åñêîì ñîþçå (ÅâðÀçÝÑ) îò 29 ìàÿ 2014 ãîäà
    Exact
    [1]
    Suffix
    èíôîðìàöèîííîå âçàèìîäåéñòâèå óïîëíîìî÷åííûõ îðãàíîâ ñòðàí-ó÷àñòíèêîâ ÅâðÀçÝÑ äðóã ñ äðóãîì, à òàêæå ñ Åâðàçèéñêîé ýêîíîìè÷åñêîé êîìèññèåé, îñóùåñòâëÿåòñÿ â ðàìêàõ ðåàëèçàöèè îáùèõ ïðîöåññîâ ñðåäñòâàìè èíòåãðèðîâàííîé èíôîðìàöèîííîé ñèñòåìû âíåøíåé è âçàèìíîé òîðãîâëè, à òàêæå ñîçäàâàåìîé íà îñíîâå ðàñøèðåíèÿ åå ôóíêöèîíàëüíûõ âîçìîæíîñòåé èíòåãðèðîâàííîé èíôîðìàöèîííîé ñèñòåìû.

2
Draft rules for registration and analysis of medical products for human use. Available from: https://goo.gl/1Uo9T5 (in Russian).
Total in-text references: 1
  1. In-text reference with the coordinate start=2676
    Prefix
    äðóã ñ äðóãîì, à òàêæå ñ Åâðàçèéñêîé ýêîíîìè÷åñêîé êîìèññèåé, îñóùåñòâëÿåòñÿ â ðàìêàõ ðåàëèçàöèè îáùèõ ïðîöåññîâ ñðåäñòâàìè èíòåãðèðîâàííîé èíôîðìàöèîííîé ñèñòåìû âíåøíåé è âçàèìíîé òîðãîâëè, à òàêæå ñîçäàâàåìîé íà îñíîâå ðàñøèðåíèÿ åå ôóíêöèîíàëüíûõ âîçìîæíîñòåé èíòåãðèðîâàííîé èíôîðìàöèîííîé ñèñòåìû. Ñîãëàñíî ïðîåêòó Ïðàâèë ðåãèñòðàöèè è ýêñïåðòèçû ëåêàðñòâåííûõ ñðåäñòâ (ËÑ) â ðàìêàõ ÅâðÀçÝÑ
    Exact
    [2]
    Suffix
    îïðåäåëåíû åäèíûå òðåáîâàíèÿ ê ïîðÿäêó ðåãèñòðàöèè, ïîäòâåðæäåíèÿ ðåãèñòðàöèè (ïåðåðåãèñòðàöèè), âíåñåíèÿ èçìåíåíèé â ðåãèñòðàöèîííîå äîñüå è ýêñïåðòèçû ëåêàðñòâåííûõ ïðåïàðàòîâ (ËÏ).  öåëÿõ ôîðìèðîâàíèÿ îáùåãî ðûíêà ËÑ â ðàìêàõ ÅâðÀçÝÑ îïðåäåëåíû òðåáîâàíèÿ ê äîêóìåíòàì è äàííûì ðåãèñòðàöèîííîãî äîñüå â ôîðìàòå îáùåãî òåõíè÷åñêîãî äîêóìåíòà, ïðåäîñòàâëÿåìîãî íà ðåãèñòðàöèþ ËÏ.

3
Guidance for Industry, ICH M4. Organization of the CTD. U. S. Department of Health and Human Services Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). August 2001.
Total in-text references: 1
  1. In-text reference with the coordinate start=9604
    Prefix
    Îò÷åòû îá èññëåäîâàíèè ýôôåêòèâíîñòè è áåçîïàñíîñòè. Îò÷åòû î ïîñòðåãèñòðàöèîííîì îïûòå ïðèìåíåíèÿ. Îáðàçöû èíäèâèäóàëüíûõ ðåãèñòðàöèîííûõ ôîðì è èíäèâèäóàëüíûå ñïèñêè ïàöèåíòîâ. Êîïèè èñïîëüçîâàííûõ ëèòåðàòóðíûõ èñòî÷íèêîâ
    Exact
    [3, 4]
    Suffix
    . Ñòàíäàðò CTD áûë ñîçäàí åùå äî ïîâñåìåñòíîãî ïåðåâîäà èíôîðìàöèè â ýëåêòðîííûé âèä. Åãî ëîãè÷åñêèì ðàçâèòèåì ñòàëà ñïåöèôèêàöèÿ eCTD (Electronic Common Technical Document, Ýëåêòðîííûé îáùèé òåõíè÷åñêèé äîêóìåíò), êîòîðàÿ ïðåäíàçíà÷åíà äëÿ ïåðåäà÷è èíôîðìàöèè ìåæäó ó÷àñòíèêàìè ôàðìàöåâòè÷åñêîé èíäóñòðèè è ðåãóëÿòîðíûìè îðãàíàìè â ýëåêòðîííîì âèäå.

4
Bunyatyan ND, Sakaeva IV, Kosareva TV, Korsun LV, Sakanyan VA. Comparative analysis of drug registration system in the Russian Federation and in the European Union. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2011; (2): 39–42 (in Russian).
Total in-text references: 2
  1. In-text reference with the coordinate start=9604
    Prefix
    Îò÷åòû îá èññëåäîâàíèè ýôôåêòèâíîñòè è áåçîïàñíîñòè. Îò÷åòû î ïîñòðåãèñòðàöèîííîì îïûòå ïðèìåíåíèÿ. Îáðàçöû èíäèâèäóàëüíûõ ðåãèñòðàöèîííûõ ôîðì è èíäèâèäóàëüíûå ñïèñêè ïàöèåíòîâ. Êîïèè èñïîëüçîâàííûõ ëèòåðàòóðíûõ èñòî÷íèêîâ
    Exact
    [3, 4]
    Suffix
    . Ñòàíäàðò CTD áûë ñîçäàí åùå äî ïîâñåìåñòíîãî ïåðåâîäà èíôîðìàöèè â ýëåêòðîííûé âèä. Åãî ëîãè÷åñêèì ðàçâèòèåì ñòàëà ñïåöèôèêàöèÿ eCTD (Electronic Common Technical Document, Ýëåêòðîííûé îáùèé òåõíè÷åñêèé äîêóìåíò), êîòîðàÿ ïðåäíàçíà÷åíà äëÿ ïåðåäà÷è èíôîðìàöèè ìåæäó ó÷àñòíèêàìè ôàðìàöåâòè÷åñêîé èíäóñòðèè è ðåãóëÿòîðíûìè îðãàíàìè â ýëåêòðîííîì âèäå.

  2. In-text reference with the coordinate start=14951
    Prefix
    Ïðàâèëà ðåãèñòðàöèè è ýêñïåðòèçû ëåêàðñòâåííûõ ñðåäñòâ äëÿ ìåäèöèíñêîãî ïðèìåíåíèÿ. Ïðîåêò. Available from: https://goo.gl/ 1Uo9T5. Ê. À. Êîøå÷êèí, Å. Ì. Ðû÷èõèíà Ðèñ. 1.Ñòðóêòóðà ýëåêòðîííîãî äîñüå
    Exact
    [4]
    Suffix
    3. Guidance for Industry, ICH M4. Organization of the CTD. U. S. Department of Health and Human Services Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER).

5
U. S. FDA Signals Intent to Reject eCTDs with Technical Issues. Available from: https:// goo.gl/7sstwY.
Total in-text references: 1
  1. In-text reference with the coordinate start=12688
    Prefix
    XML-ôàéë ñîäåðæèò ìåòàäàííûå îáî âñåõ ýëåìåíòàõ ñîîáùåíèÿ è îãëàâëåíèå âñåãî ñîäåðæèìîãî äîñüå, ÷òî èñïîëüçóåòñÿ êàê íàâèãàöèÿ. Óïðàâëåíèå æèçíåííûì öèêëîì ñîîáùåíèÿ çàêëþ÷àåòñÿ â õðàíåíèè ïåðâè÷íîãî ñîîáùåíèÿ è ïîñëåäóþùèõ äîïîëíåíèé ê íåìó ñ ñîîòâåòñòâóþùåé èíêðåìåíòíîé íóìåðàöèåé
    Exact
    [5–7]
    Suffix
    . Ñ ÿíâàðÿ 2016 ãîäà âñòóïèëà â ñèëó ïîïðàâêà ê Ôåäåðàëüíîìó çàêîíó îò 12.04.2010 ã. ¹ 61-ÔÇ «Îá îáðàùåíèè ëåêàðñòâåííûõ ñðåäñòâ »(äàëåå — Çàêîí), ðåãëàìåíòèðóþùàÿ íåîáõîäèìîñòü ïðåäñòàâëåíèÿ çàÿâèòåëÿìè è ðàçðàáîò÷èêàìè ËÑ äëÿ ðåãèñòðàöèè â Ðîññèéñêîé Ôåäåðàöèè è ïðîâåäåíèÿ äðóãèõ ñîïóòñòâóþùèõ ðåãóëÿòîðíûõ ïðîöåäóð ðåãèñòðàöèîííûõ äîñüå â ôîðìàòå îáùåãî òåõíè÷åñêîãî äîêóìåíòà.

8
Federal Law of the Russian Federation of 22.12.2014 No. 429-FZ «On Amending the Federal Law «On Circulation of Medicines» (in Russian). Available from: https://goo.gl/VOzDjU (in Russian).
Total in-text references: 1
  1. In-text reference with the coordinate start=13215
    Prefix
    äàëåå — Çàêîí), ðåãëàìåíòèðóþùàÿ íåîáõîäèìîñòü ïðåäñòàâëåíèÿ çàÿâèòåëÿìè è ðàçðàáîò÷èêàìè ËÑ äëÿ ðåãèñòðàöèè â Ðîññèéñêîé Ôåäåðàöèè è ïðîâåäåíèÿ äðóãèõ ñîïóòñòâóþùèõ ðåãóëÿòîðíûõ ïðîöåäóð ðåãèñòðàöèîííûõ äîñüå â ôîðìàòå îáùåãî òåõíè÷åñêîãî äîêóìåíòà. Ðîññèéñêèé ôîðìàò ïî ñâîåé êîíöåïöèè áëèçîê ê CTD, îäíî èç îòëè÷èé çàêëþ÷àåòñÿ â îòñóòñòâèè â ðîññèéñêîé âåðñèè ìîäóëÿ 2 ñ îáîáùàþùåé èíôîðìàöèåé
    Exact
    [8]
    Suffix
    . Ôîðìàò eCTD èëè åãî ðîññèéñêèé ýëåêòðîííûé àíàëîã íàïðÿìóþ â Çàêîíå íå ïðåäóñìàòðèâàåòñÿ, íî íîðìà, ïðåäïèñûâàþùàÿ ïðåäñòàâëåíèå äîêóìåíòîâ ðåãèñòðàöèîííîãî äîñüå â óïîëíîìî÷åííûé ôåäåðàëüíûé îðãàí èñïîëíèòåëüíîé âëàñòè â ýëåêòðîííîì âèäå, êîñâåííî óêàçûâàåò íà íåîáõîäèìîñòü åãî ñîçäàíèÿ, êàê ìèíèìóì, íà óðîâíå èíôîðìàöèîííûõ ñèñòåì Ìèíèñòåðñòâà çäðàâîîõðàíåíèÿ Ðîññèéñêîé Ôåäåðàöèè.

9
Merkulov VA, Bunyatyan ND, Koshechkin KA, Sboev GA. Current status and future development of the single information space of the FSBI «SCEMAP» of the Ministry of Health of the Russian Federation. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 2013; (4): 38–41 (in Russian).
Total in-text references: 1
  1. In-text reference with the coordinate start=13926
    Prefix
    Ðàçâèòèå íàó÷íî-òåõíè÷åñêîãî ïðîãðåññà, ñîçäàíèå åäèíîãî ðûíêà ËÑ íà óðîâíå ñòðàí-÷ëåíîâ Åâðàçèéñêîãî ýêîíîìè÷åñêîãî ñîþçà è ðàçðàáîòêà åäèíûõ òðåáîâàíèé ê ôîðìàòó ïðåäñòàâëÿåìûõ ðåãèñòðàöèîííûõ äîñüå íåèçáåæíî âåäóò ê ñêîðîìó âíåäðåíèþ ôîðìàòà eCTD. Ãàðìîíèçàöèÿ ïðàâèë ïðåäîñòàâëåíèÿ èíôîðìàöèè î ËÏ â ðåãóëÿòîðíûå îðãàíû
    Exact
    [9]
    Suffix
    ÿâëÿåòñÿ âàæíûì øàãîì íà ïóòè óñòðàíåíèÿ áàðüåðîâ äëÿ äîñòóïà íà ðûíîê ñîâðåìåííûõ âûñîêîýôôåêòèâíûõ ËÑ, â òîì ÷èñëå ïðåïàðàòîâ äëÿ ëå÷åíèÿ îðôàííûõ çàáîëåâàíèé. Ïðèìåíåíèå åäèíîãî ýëåêòðîííîãî ôîðìàòà ïðåäîñòàâëåíèÿ äîñüå ïîçâîëèò àâòîìàòèçèðîâàòü êîíòðîëü çà ïîëíîòîé íàïðàâëÿåìûõ äîêóìåíòîâ, èíòåãðèðîâàòü èíôîðìàöèîííûå ñèñòåìû ðàçðàáîò÷èêîâ ëåêàðñòâåííûõ ïðåïàðàòîâ è ðåãóëÿòîðíûõ îðãàíîâ.