EMA: Draft GL for OIPs [BE/BA News]

posted by Ohlbe – France, 2024-04-22 16:07 (55 d 13:37 ago) – Posting: # 23961
Views: 1,173

Dear Chirag,

❝ Since this is my first post, I apologize for any errors.

No error, and welcome to the forum.

❝ Upon reading, I noticed that the recently introduced guidelines still relate to Directive 2001/20/EC rather than 536/2014.

You're absolutely right, the guideline should refer to the Clinical Trial Regulation and no longer to the Clinical Trial Directive. There was a first public consultation to revise this guideline in 2017 (before the CTR came into force), and it looks like they failed to update this paragraph after that.

The document just published is again a draft for public consultation. Hopefully this will be pointed out and corrected.


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