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

posted by Chirag – India, 2024-04-22 06:37 (56 d 00:33 ago) – Posting: # 23960
Views: 1,206

(edited by on 2024-04-22 06:48)

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.


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