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An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe

PURPOSE: The aim of this study is to provide a comprehensive overview of the outcomes of marketing authorisation applications via the mutual recognition and decentralised procedures (MRP/DCP) and assess determinants of licensing failure during CMDh referral procedures. METHODS: All MRP/DCP procedure...

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Autores principales: Ebbers, Hans C., Langedijk, Joris, Bouvy, Jacoline C., Hoekman, Jarno, Boon, Wouter P. C., de Jong, Jean Philippe, De Bruin, Marie L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4564446/
https://www.ncbi.nlm.nih.gov/pubmed/26204969
http://dx.doi.org/10.1007/s00228-015-1904-1
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author Ebbers, Hans C.
Langedijk, Joris
Bouvy, Jacoline C.
Hoekman, Jarno
Boon, Wouter P. C.
de Jong, Jean Philippe
De Bruin, Marie L.
author_facet Ebbers, Hans C.
Langedijk, Joris
Bouvy, Jacoline C.
Hoekman, Jarno
Boon, Wouter P. C.
de Jong, Jean Philippe
De Bruin, Marie L.
author_sort Ebbers, Hans C.
collection PubMed
description PURPOSE: The aim of this study is to provide a comprehensive overview of the outcomes of marketing authorisation applications via the mutual recognition and decentralised procedures (MRP/DCP) and assess determinants of licensing failure during CMDh referral procedures. METHODS: All MRP/DCP procedures to the Co-ordination group for Mutual recognition and Decentralised procedures–human (CMDh) during the period from January 2006 to December 2013 were analysed. Reasons for starting referral procedures were scored. In addition, a survey under pharmaceutical companies was performed to estimate the frequency of licensing failure prior to CMDh referrals. RESULTS: During the study period, 10392 MRP/DCP procedures were finalized. Three hundred seventy-seven (3.6 %) resulted in a referral procedure, of which 70 (19 %) resulted in licensing failure, defined as refusal or withdrawal of the application. The frequency of CMDh referrals decreased from 14.5 % in 2006 to 1.6 % in 2013. Of all referrals, 272 (72 %) were resolved through consensus within the CMDh, the remaining 105 (28 %) were resolved at the level of the CHMP. Most referrals were started because of objections raised about the clinical development program. Study design issues and objections about the demonstration of equivalence were most likely to result in licensing failure. An estimated 11 % of all MRP/DCP procedures resulted in licensing failure prior to CMDh referral. CONCLUSION: Whereas the absolute number of MRP/DCP procedures resulting in a referral has reduced substantially over the past years, no specific time trend could be observed regarding the frequency of referrals resulting in licensing failure. Increased knowledge at the level of companies and regulators has reduced the frequency of late-stage failure of marketing applications via the MRP/DCP. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00228-015-1904-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-45644462015-09-15 An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe Ebbers, Hans C. Langedijk, Joris Bouvy, Jacoline C. Hoekman, Jarno Boon, Wouter P. C. de Jong, Jean Philippe De Bruin, Marie L. Eur J Clin Pharmacol Pharmacoepidemiology and Prescription PURPOSE: The aim of this study is to provide a comprehensive overview of the outcomes of marketing authorisation applications via the mutual recognition and decentralised procedures (MRP/DCP) and assess determinants of licensing failure during CMDh referral procedures. METHODS: All MRP/DCP procedures to the Co-ordination group for Mutual recognition and Decentralised procedures–human (CMDh) during the period from January 2006 to December 2013 were analysed. Reasons for starting referral procedures were scored. In addition, a survey under pharmaceutical companies was performed to estimate the frequency of licensing failure prior to CMDh referrals. RESULTS: During the study period, 10392 MRP/DCP procedures were finalized. Three hundred seventy-seven (3.6 %) resulted in a referral procedure, of which 70 (19 %) resulted in licensing failure, defined as refusal or withdrawal of the application. The frequency of CMDh referrals decreased from 14.5 % in 2006 to 1.6 % in 2013. Of all referrals, 272 (72 %) were resolved through consensus within the CMDh, the remaining 105 (28 %) were resolved at the level of the CHMP. Most referrals were started because of objections raised about the clinical development program. Study design issues and objections about the demonstration of equivalence were most likely to result in licensing failure. An estimated 11 % of all MRP/DCP procedures resulted in licensing failure prior to CMDh referral. CONCLUSION: Whereas the absolute number of MRP/DCP procedures resulting in a referral has reduced substantially over the past years, no specific time trend could be observed regarding the frequency of referrals resulting in licensing failure. Increased knowledge at the level of companies and regulators has reduced the frequency of late-stage failure of marketing applications via the MRP/DCP. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00228-015-1904-1) contains supplementary material, which is available to authorized users. Springer Berlin Heidelberg 2015-07-25 2015 /pmc/articles/PMC4564446/ /pubmed/26204969 http://dx.doi.org/10.1007/s00228-015-1904-1 Text en © The Author(s) 2015 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Pharmacoepidemiology and Prescription
Ebbers, Hans C.
Langedijk, Joris
Bouvy, Jacoline C.
Hoekman, Jarno
Boon, Wouter P. C.
de Jong, Jean Philippe
De Bruin, Marie L.
An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe
title An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe
title_full An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe
title_fullStr An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe
title_full_unstemmed An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe
title_short An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe
title_sort analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in europe
topic Pharmacoepidemiology and Prescription
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4564446/
https://www.ncbi.nlm.nih.gov/pubmed/26204969
http://dx.doi.org/10.1007/s00228-015-1904-1
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