SEMANTIC MANAGEMENT OF THE SUBMISSION PROCESS FOR MEDICINAL PRODUCTS AUTHORIZATION
The pharmaceutical corporations are confronting big challenges when applying for Marketing Authorization (MA) licenses in extremely restricted environments, which are built around a variety of regulations, legislations and regulatory requirements. For novel pharmaceutical products, companies are required to submit thousands of pages of documents as part of the regulatory review process, which very often restricts companies’ and governments’ initiatives to speed up ‘time-to-market’ for medicines and minimize costs of the whole process. Furthermore, pharmaceutical companies are supposed to submit their Marketing Authorization Applications (MAA) according to their national specifications. Thus the formatting and organization of MA submission documents are dictated by the regulatory requirements of each country. Hence, pharmaceutical companies had to reformat and adjust the contents of MAA if they were applying for MA licenses across the world.
KeywordsEuropean Union Market Authorization Document Type Definition License Authority Existential Restriction
- 1.Datafarm Inc, “eCTD: Will You Be Ready for 2009”, epc, Data Management and IT Solutions, available at http://www.datafarminc.com/PDF/CS-EPC.pdf, 2007.
- 2.T. Felgate, “The evolution of the eCTD”, available at http://www.appliedregulatory.com/articles/FelgateTPharmafocusMarch2009.pdf, 2009.
- 3.G.E. Overend, “Introduction to eCTD and first principles. TOPRA”, The Organisation for Professionals in Regulatory Affairs, available at http://www.topra.org/files/focus1_0.pdf, 2008.
- 4.A. Neuer, “Learning to embrace the eCTD”, Bio IT World, available at http://www.bio-itworld.com/issues/2009/may-jun/feature.html, 2009.
- 5.iRegulatory Ltd, “Building eCTDs”, available at http://www.ectd-resources.com/readarticle.php?article_id=7, 2008.
- 6.A. Goel and M.K. Sundararajan, “Managing Electronic submissions through eCTD with strategic partners”, eyeforpharma Briefings, Guest Feature, available at http://www.eyeforpharma.com/briefing/ectdfinal.pdf, 2006.
- 7.J. Pickett, “XML a frequent problem with eCTD submissions; speaker says refuse-to-files are painful”, BioResearch Compliance Report Electronic clinical trials, available at http://www.entrepreneur.com/tradejournals/article/175407584.html, 2007.
- 8.C. Mathis, “A History of eSubmission” epc, Data Management and IT Solutions, available at http://www.reg123.com/Documents/LORENZ_EPC0609.pdf, 2009.
- 9.D. Duggan, “Implications of eCTD errors”, FDA/CDER/OBPS, available at http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM166278.pdf, 2008.
- 10.B.M Noel, “Managing a Major eCTD Filing”, Clinical Trials, Issue 11, http://www.pharmafocusasia.com/clinical_trials/managing.htm, 2009.
- 11.P. Boe, “Templates: Taking the first step towards eCTD submissions in Europe”, available at http://www.emwa.org/JournalArticles/JA_V15_I1_Boe1.pdf, 2006.
- 12.EGA, “European Generic Medicine Association: Authorisation”, available at http://www.egagenerics.com/gen-authorisation.htm, 2004.
- 13.B. Avison, “Pharma Market Authorization Strategies: A guide to launching drugs quickly and efficiently in Europe”, Business Insights, available at http://www.globalbusinessinsights.com/content/rbhc0093t.pdf, 2003.
- 14.P. Evers, “Pharmaceutical Regulatory Affairs Outlook 2002”, available at https://www.globalbusinessinsights.com/content/rbhc0072m.pdf, 2002.
- 15.FDA, “Development & Approval Process (DRUGS)”, available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm, 2009, 2009.
- 16.P. James and G. Archbold, “The secret life of a dossier”, available at http://www.publicservice.co.uk/article.asp?publication=European%20Union&id=275&content_name=Health&article=8395, 2007.
- 17.J. Ramsden, “Common Technical Document”, Pharmabiz, available at http://www.pharmabiz.com/article/detnews.asp?articleid=11405§ionid=46, 2002.
- 18.G. Ventura, “Optimizing Your eCTD Submission: How to Achieve an Efficient and Timely Review”, available at http://www.forumsci.co.il/Landau/routine%20updates/drugs/Optimizing%20Your%20eCTD%20Submission.doc, 2008.
- 19.Laszlo Letter, “eCTD Software Vendors”, [online], Laslo, http://laszloletter.typepad.com/the_laszlo_letter/2007/02/ectd_software_v.html, 2007.
- 20.EXTEDO GmbH, “EURS is Yours”, EXTEDO, available at http://www.extedo.com/products/submission-reviewing-validation/eurs-is-yours/, 2009.
- 21.Global Submit, “eCTD validation for submission assurance and quality”, available at http://globalsubmit.com/home/Products/VALIDATE/tabid/243/Default.aspx, 2009.
- 22.Brilliant Leap Blog, “The eCTD/ Document Management Connection- What say the vendors”, Document Content Management, available at http://www.brilliantleap.com/blog/2008/09/the-ectd-document-management-connection--what-say-the-vendors.html, 2008.
- 23.R. Juric and J. Juric, “Applying Component Based Modelling in the Process of Evaluation of Medicinal Products”, Proceedings of the 11th International Conference on Integrated Design and Process Technology (IDPT), 2002.Google Scholar
- 24.L. Slevin, R. Shojanoori, and R. Juric, “Developing a database for automating regulatory affairs in the pharmaceutical industry”, Journal of Integrated Design and Process Science, Vol. 9, Issue 4, pp.1–11, 2005.Google Scholar
- 25.R. Juric, L. Slevin, R. Shojanoori, and S. Williams, “Software Support in Automation of Medicinal Product Evaluations”, Proceedings of the International Council on Medical and Care Computerics event, (ICMCC) 2005.Google Scholar
- 26.R. Juric, and S. Williams, “Experiences of Creating COTS Components when Automating Medicinal Product Evaluation”, Proceedings of the 16th International Conference on Software Engineering and Knowledge Engineering (SEKE), 2005.Google Scholar
- 27.European Commission, “Volume 2B Notice to Applicants Medicinal products for human use”, available at http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/b/update_200805/ctd_05-2008.pdf, 2008.
- 29.J.S. Brunner, L. Ma, C. Wang, L. Zhang, D.C. Wolfson, Y. Pan, and K. Srinivas, “Explorations in the Use of Semantic Web Technologies for Product Information Management”, Proceedings of the World Wide Web Conference, 2007.Google Scholar
- 30.Protégé, “Welcome to protégé”, available at http://protege.stanford.edu/, 2009.