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Digital Systems for eCTD Creation on the Pharmaceutical Market of the Eurasian Economic Union

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Part of the book series: Smart Innovation, Systems and Technologies ((SIST,volume 193))

Abstract

Pharmaceutical market integration is highly dependent on digital technologies in general and the Internet in particular. The work aims are to study the available software for creating Electronic common technical documents and the possibility of its application on the Eurasian Economic Union market. To obtain information, the survey was performed based on employees of pharmaceutical companies, which were interviewed to identify the software they are using or plan to use. Based on the obtained results, a list of preferred software was compiled. It contains 9 software products. As part of the second phase of the study, a survey of developers of designated software solutions was conducted. Results showed that for pharmaceutical companies operating in the Eurasian Economic Union region, the issue of software readiness for working with the requirements of domestic regulators is of particular importance. Most foreign software products can be localized only after significant modifications. Domestic software solutions are just beginning to appear and in some cases are highly specialized. For example, programs for planning and meeting regulatory deadlines in the market are represented by single products.

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References

  1. FDA approves the first drug with an indication for treatment of smallpox. FDA [Electronic resource]. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-indication-treatment-smallpox. Accessed 27 Dec 2019

  2. Пpaвилa peгиcтpaции и экcпepтизы лeкapcтвeнныx cpeдcтв для мeдицинcкoгo пpимeнeния [Electronic resource]. https://docs.eaeunion.org/ria/ru-ru/011597/ria_01072015_att.pdf

  3. 5 Reasons to choose the EXTEDO suite for Regulatory Information Management [Electronic resource]. https://3.imimg.com/data3/LN/TC/MY-16226817/extedosuite-for-global-eregulatory-compliance-management.pdf

  4. Fan, Y.: Opportunities, challenges and countermeasures for the implementation of eCTD. Chin. J. New Drugs. 28(16), 1997–2003 (2019)

    Google Scholar 

  5. Xia, L., Zeng, S.: A review of the common technical document (CTD) regulatory dossier for generic drugs in China. Chin. Pharm. J. 51(4), 329–334 (2016)

    Google Scholar 

  6. Ayling, C.: The common European submission platform (CESP)-a first-time perspective Regulatory Rapporteur. TOPRA 10(12), 31–32 (2013)

    Google Scholar 

  7. Menges, K.: Elektronische einreichung von zulassungsdossiers bei den behörden: Pro und contra für die beiden formate eCTD und non-eCTD e-submission (NeeS). Pharmazeutische Industrie 72(7), 1148–1158 (2010)

    Google Scholar 

  8. Nordfjeld, K.: Strasberger V: creating eCTD applications. J. Generic Med. 3(2), 140–146 (2006)

    Article  Google Scholar 

  9. Kainz, A., Harmsen, S.: Einsatz eines dossier-management-systems in der arzneimittelindustrie/auswahl, einfhrung und praktische erfahrungen. Pharmazeutische Industrie 65(5 A), 511–519 (2003)

    Google Scholar 

  10. Franken, A.: Zukunft des regulatorischen e-managements bei der arzneimittelzulassung. Pharmazeutische Industrie 65(5 A), 491–497 (2003)

    Google Scholar 

  11. Bowers, A., Shea, M.E.: Transatlantic planning: using eCTD format US INDs as a planning and preparation tool for EU MAAs. Regul. Rapp. TOPRA 11(2), 28–31 (2014)

    Google Scholar 

  12. Casselberry, B.: Recent changes to dossier format requirements: in some emerging markets. Regul. Rapp. 9(4), 18–19 (2012)

    Google Scholar 

  13. Koshechkin, K., Lebedev, G., Tikhonova, J.: Regulatory information management systems, as a means for ensuring the pharmaceutical data continuity and risk management. In: Smart Innovation, Systems and Technologies, vol. 142, pp. 265–274. Springer Science and Business Media Deutschland GmbH (2019)

    Google Scholar 

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Correspondence to Konstantin Koshechkin .

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Koshechkin, K., Lebedev, G., Zykov, S. (2020). Digital Systems for eCTD Creation on the Pharmaceutical Market of the Eurasian Economic Union. In: Czarnowski, I., Howlett, R., Jain, L. (eds) Intelligent Decision Technologies. IDT 2020. Smart Innovation, Systems and Technologies, vol 193. Springer, Singapore. https://doi.org/10.1007/978-981-15-5925-9_32

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