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

作者：Ebbers Hans C^*; Langedijk Joris; Bouvy Jacoline C; Hoekman Jarno; Boon Wouter P C; de Jong Jean Philippe; De Bruin Marie L

来源：European Journal of Clinical Pharmacology, 2015, 71(10): 1237-1244.

DOI：10.1007/s00228-015-1904-1

• MRP/DCP procedure
• CMDh referrals
• Marketing authorisation (MA)
• Regulatory science
• Pharmaceutical regulation

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.
Conclusions 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.

• 出版日期2015-10