Ohlbe
★★★

France,
2025-07-10 18:25
(355 d 21:19 ago)

Posting: # 24408
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 Danish Agency requesting submission of CDISC data [BE/BA News]

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Dear all,

Following a pilot phase, the Danish Medicines Agency has announced that they would request the submission of BE data in CDISC format for all national applications and for decentralised or mutual recognition procedures when they act as Reference Member State, from 1st September 2025.
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Regards
Ohlbe
 
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