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XenaLives

12/14/17 11:54 AM

#134335 RE: anders2211 #134332

It seems that there is a delay there also - from your link:


The first-published and last-updated dates in the search results refer to the day the document was first published and last revised online. Check the date on the document itself for information on when the document itself was finalised or last updated prior to publication.




I also found this interesting:


The European Medicines Agency (EMA) was formed in 1995 with funding from the EU, pharmaceutical industry, and member states (19). The EMA was charged with harmonizing processes in the member state regulatory agencies to reduce annual costs to drug companies (that previously were required to obtain separate approvals in each member state) as well as to eliminate competition-restricting regulation in sovereign states. However, the EMA does not oversee all drug approvals the way the FDA does in the United States. In Europe, there are 4 routes by which a drug can be approved, depending on the drug class and manufacturer preference (6).

http://www.sciencedirect.com/science/article/pii/S2452302X16300638#bib18





Apparently they have delayed full implementation of a centralized database until 2019..

http://www.raps.org/Regulatory-Focus/News/2017/06/16/27929/Application-of-EU-Clinical-Trial-Regulation-Delayed-to-2019/