Helmut
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Vienna, Austria,
2024-04-19 17:40
(89 d 09:49 ago)

Posting: # 23959
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 EMA: Draft GL for OIPs [BE/BA News]


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Chirag
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India,
2024-04-22 06:37
(86 d 20:53 ago)

(edited by on 2024-04-22 06:48)
@ Helmut
Posting: # 23960
Views: 1,436
 

 EMA: Draft GL for OIPs

Dear Helmut,

Thank you for sharing.

Upon reading, I noticed that the recently introduced guidelines still relate to Directive 2001/20/EC rather than 536/2014. To the best of my knowledge, the revised guideline is effective from January 31, 2023. Trials that were authorized under the Clinical Trials Directive may be extended until January 31, 2025. If they are not finished by then, they will likewise be governed by the Clinical Trials Regulation and need to be registered in CTIS. I would like everyone to help me with this.

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

Regards,
Chirag
Ohlbe
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France,
2024-04-22 16:07
(86 d 11:22 ago)

@ Chirag
Posting: # 23961
Views: 1,405
 

 EMA: Draft GL for OIPs

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.

Regards
Ohlbe
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