Just remember that based on your medicinal product, you may have to choose CP because if the product is for advanced therapy or other treatments such as for cancer or viral diseases. The answer to your questions really depends strongly on your organisations marketing strategy, because a CP gives you sort of a "one and done" approach where DCP can let you introduce into different countries over a period of time. The DCP can be shorter for subsequent MA, but you must go through an initial Reference Member State first, but can choose multiple Concerned Member States at the same time. There are pros and cons to each of them including timing, dealing with EU Commission versus RMS, review of dossier, etc., would recommend reading more about them on the EU Health website, RAPS Fundamentals Handbook, and TOPRA has nice information also.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 05-May-2018 18:54
From: Anonymous Member
Subject: Centralized vs. Decentralized procedure
This message was posted by a user wishing to remain anonymous
What would be the strategy behind choosing the decentralized procedure versus the centralized procedure for an MAA?