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Marketing Authorisation Application file

A literature review was conducted between 10 and 12 October 2022, with the expression “Marketing Authorisation Application file”, in English and in French, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis Nexis, Lextenso, Navis, Doctrinal Plus, Westlaw UK, Brill, Cairn, Bibliothèque numérique en droit de la santé, Wiley Online Library, Lamyline Reflex, Cambridge University Press Revues – Archives ISTEX, De Gruyter revues – Archives ISTEX, Encyclopédie Max Planck de droit international public, JSTOR, Law Review Commons, OpenEdition Journals, ScienceDirect, Springer Nature, Web of Science, Google Scholar and PubMed. Please find below the most relevant results of this review.

 

Amaouche, Nadia, Hélène Casaert Salomé, Olivier Collignon, Mariana Roldao Santos, and Constantinos Ziogas. « Marketing Authorisation Applications Submitted to the European Medicines Agency by Small and Medium-Sized Enterprises: An Analysis of Major Objections and Their Impact on Outcomes ». Drug Discovery Today 23, no 10 (October 2018): 1801-1805.
https://doi.org/10.1016/j.drudis.2018.06.018.

Branch, Sarah K. « Guidelines from the International Conference on Harmonisation (ICH) ». Journal of Pharmaceutical and Biomedical Analysis, Quantitative NMR Spectroscopy, 38, no 5 (10 August 2005): 798-805.
https://doi.org/10.1016/j.jpba.2005.02.037.

Cartwright, Anthony C. « The Electronic Common Technical Document ». International Journal of Pharmaceutical Medicine 20, no 3 (1st June 2006): 149-158.
https://doi.org/10.2165/00124363-200620030-00001.

Carvalho, Marta, Ana Paula Martins, and Bruno Sepodes. « Hurdles in Gene Therapy Regulatory Approval: A Retrospective Analysis of European Marketing Authorization Applications ». Drug Discovery Today 24, no 3 (March 2019): 823-828.
https://doi.org/10.1016/j.drudis.2018.12.007.

Chakraborty, Krishnasis, and Kavita Yadav. « Drug Approval Process in US, Europe and India and Its Regulatory Requirements: A Review ». International Journal of Drug Regulatory Affairs., s. d., 10.

« Conditions de délivrance d’une autorisation de mise sur le marché de produits pharmaceutiques selon la procédure allégée dite « bibliographique » ». Recueil Lebon – Recueil des décisions du conseil d’Etat | Dalloz, 31 December 2019.

Cremiers, F. de. « [ICH M4: the standardized international registration dossier or “C.T.D.” (common technical document)] ». Annales Pharmaceutiques Françaises 57, no 2 (March 1999): 143-146.

Ebbers, Hans C., Joris Langedijk, Jacoline C. Bouvy, Jarno Hoekman, Wouter P. C. Boon, Jean Philippe de Jong, and Marie L. De Bruin. « An Analysis of Marketing Authorisation Applications via the Mutual Recognition and Decentralised Procedures in Europe ». European Journal of Clinical Pharmacology 71, no 10 (October 2015): 1237-1244.
https://doi.org/10.1007/s00228-015-1904-1.

Garg, Varun, Shruti Chopra, Sachin Kumar Singh, Monica Gulati, Bimlesh Kumar, and Neeraj Mittal. « A Comparative Study of Common Technical Document in Different Regulated Market ». Journal of Pharmacy Research 11, no 8 (2017): 11.

Gelman, Rita Segal. « International Marketing Applications According to the ICH CTD Format: Comparison of Structure and Document Requirements ». The Quality Assurance Journal 10, no 2 (2006): 111-120.
https://doi.org/10.1002/qaj.374.

Hofer, Matthias P., Hanna Hedman, Maria Mavris, Franz Koenig, Thorsten Vetter, Martin Posch, Spiros Vamvakas, Jan Regnstrom, and Stiina Aarum. « Marketing Authorisation of Orphan Medicines in Europe from 2000 to 2013 ». Drug Discovery Today 23, no 2 (February 2018): 424-433.
https://doi.org/10.1016/j.drudis.2017.10.012.

Jordan, Debbie. « An Overview of the Common Technical Document (CTD) Regulatory Dossier ». Medical Writing 23, no 2 (1st June 2014): 101-105.
https://doi.org/10.1179/2047480614Z.000000000207.

Juillet, Y. « Internationalization of Regulatory Requirements ». Fundamental & Clinical Pharmacology 17, no 1 (2003): 21-25.
https://doi.org/10.1046/j.1472-8206.2003.00118.x.

Lee, J. John. « What Is Past Is Prologue: The International Conference on Harmonization and Lessons Learned from European Drug Regulations Harmonization Comment ». University of Pennsylvania Journal of International Economic Law 26, no 1 (2005): 151-192.

Macdonald, Judith C., David C. Isom, Daniel D. Evans, and Katy J. Page. « Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem—Are We Ready for a Revolution? » Frontiers in Medicine 8 (2021).
https://www.frontiersin.org/articles/10.3389/fmed.2021.660808.

Makvana, Pratik, and Dr Dilip Maheshwari. « Regulatory Requirements for Marketing Authorization of Generic Parentral Product in European Countries by Decentralised Procedure » 4, no 2 (2014): 5.

McBlane, James W. « Regulatory Landscape for Cell Therapy – EU View ». Biologicals 43, no 5 (September 2015): 433-436.
https://doi.org/10.1016/j.biologicals.2015.04.004.

Menges, K. « Harmonisation of the Marketing Authorisation Application dossier: Perspectives due to harmonised requirements. Assessing Rules and the Common Technical Document ». Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz 51, no 7 (July 2008): 748-756. https://doi.org/10.1007/s00103-008-0581-y.

Molzon, Justina, A Giaquinto, L Lindstrom, T Tominaga, M Ward, P Doerr, L Hunt, and L Rago. « The Value and Benefits of the International Conference on Harmonisation to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health ». Clinical Pharmacology & Therapeutics 89, no 4 (2011): 503-512.
https://doi.org/10.1038/clpt.2011.10.

Molzon, Justina. « The Common Technical Document: The Changing Face of the New Drug Application ». Nature Reviews Drug Discovery 2, no 1 (January 2003): 71-74.
https://doi.org/10.1038/nrd990.

Molzon, Justina A. « The International Conference on Harmonization Common Technical Document – Global Submission Format ». Food and Drug Law Journal 60, no 3 (2005): 447-452.

Oberweis, Caroline Veronique, Juan Antonio Marchal, Elena López-Ruiz, and Patricia Gálvez-Martín. « A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products ». Tissue Engineering Part B: Reviews 26, no 2 (April 2020): 181-196.
https://doi.org/10.1089/ten.teb.2019.0315.

Padmaja, Burri, M. V. Nagabhushanam, Brahmaiah Bonthagarala, D. Nagarjuna Reddy, and G. Ramakrishna. « Dossier Preparation Requirements for Generic Drugs of Usa, Europe & India ». Indo American Journal of Pharmaceutical Sciences 5, no 8 (August 2018): 7251-7263.
https://doi.org/10.5281/zenodo.1341334.

Pellegrini, Graziella, Diego Ardigò, Giovanni Milazzo, Giorgio Iotti, Paolo Guatelli, Danilo Pelosi, and Michele De Luca. « Navigating Market Authorization: The Path Holoclar Took to Become the First Stem Cell Product Approved in the European Union ». STEM CELLS Translational Medicine 7, no 1 (2018): 146-154.
https://doi.org/10.1002/sctm.17-0003.

Regnstrom, Jan, Franz Koenig, Bo Aronsson, Tatiana Reimer, Kristian Svendsen, Stelios Tsigkos, Bruno Flamion, Hans-Georg Eichler, and Spiros Vamvakas. « Factors Associated with Success of Market Authorisation Applications for Pharmaceutical Drugs Submitted to the European Medicines Agency ». European Journal of Clinical Pharmacology 66, no 1 (January 2010): 39-48.
https://doi.org/10.1007/s00228-009-0756-y.

Roth, Robert I. « Preparing the Common Technical Document for Registration of Pharmaceuticals for Human Use (CTD)—Insights and Recommendations ». Drug Information Journal 42, no 2 (March 2008): 149-159.
https://doi.org/10.1177/009286150804200207.

Tanniou, Julien, Steven Teerenstra, Sagal Hassan, Andre Elferink, Ingeborg van der Tweel, Christine Gispen-de Wied, and Kit C. B. Roes. « European Regulatory Use and Impact of Subgroup Evaluation in Marketing Authorisation Applications ». Drug Discovery Today 22, no 12 (1st December 2017): 1760-1764. https://doi.org/10.1016/j.drudis.2017.09.012.

Todić, Maida. « Dossier for Marketing Authorization in the European Union ». Bosnian Journal of Basic Medical Sciences 3, no 1 (March 2003): 56-60.
https://doi.org/10.17305/bjbms.2003.3572.