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X Demographics
Mendeley readers
Attention Score in Context
| Title |
An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe
|
|---|---|
| Published in |
European Journal of Clinical Pharmacology, July 2015
|
| DOI | 10.1007/s00228-015-1904-1 |
| Pubmed ID | |
| Authors |
Hans C. Ebbers, Joris Langedijk, Jacoline C. Bouvy, Jarno Hoekman, Wouter P. C. Boon, Jean Philippe de Jong, Marie L. De Bruin |
| Abstract |
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. 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. 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. 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. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Practitioners (doctors, other healthcare professionals) | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 45 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 45 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 7 | 16% |
| Student > Master | 7 | 16% |
| Student > Ph. D. Student | 6 | 13% |
| Other | 4 | 9% |
| Student > Bachelor | 2 | 4% |
| Other | 8 | 18% |
| Unknown | 11 | 24% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 9 | 20% |
| Medicine and Dentistry | 9 | 20% |
| Social Sciences | 3 | 7% |
| Business, Management and Accounting | 2 | 4% |
| Unspecified | 2 | 4% |
| Other | 7 | 16% |
| Unknown | 13 | 29% |
Attention Score in Context
This research output has an Altmetric Attention Score of 4. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 25 April 2023.
All research outputs
#7,266,774
of 23,668,780 outputs
Outputs from European Journal of Clinical Pharmacology
#805
of 2,610 outputs
Outputs of similar age
#82,254
of 264,412 outputs
Outputs of similar age from European Journal of Clinical Pharmacology
#15
of 32 outputs
Altmetric has tracked 23,668,780 research outputs across all sources so far. This one has received more attention than most of these and is in the 68th percentile.
So far Altmetric has tracked 2,610 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.1. This one has gotten more attention than average, scoring higher than 68% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 264,412 tracked outputs that were published within six weeks on either side of this one in any source. This one has gotten more attention than average, scoring higher than 67% of its contemporaries.
We're also able to compare this research output to 32 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 56% of its contemporaries.