Bachmann Peter
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger Allee 3, Bonn, BRD.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2008 Jul;51(7):722-30. doi: 10.1007/s00103-008-0578-6.
The Mutual Recognition Procedure (MRP) and the Decentralised Procedure (DCP), which were first established in late 2005, can be regarded as the backbone for marketing authorisation of medicinal products in the European Community (EC) and the European Economic Area (EEA). Both procedures are compared and advantages and disadvantages are discussed. However, the focus is more related to current developments than the detailed comparison of both procedures. The role of the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMD(h)) and the decision making process in relation to the MRP and DCP is also discussed.
相互认可程序（MRP）和分散程序（DCP）于2005年末首次确立，可被视为欧洲共同体（EC）和欧洲经济区（EEA）药品上市许可的支柱。对这两种程序进行了比较，并讨论了其优缺点。然而，重点更多地与当前的发展相关，而非对这两种程序进行详细比较。还讨论了人用药品相互认可和分散程序协调小组（CMD(h)）的作用以及与MRP和DCP相关的决策过程。
