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RegisterSAE Reporting [Regulatives / Guidelines]
Dear Mr. Santosh
As per schedule Y "Any unexpected serious adverse event (SAE) (as defined in GCP Guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study (see Appendix XI)."
As per Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies (published December-12)
BA/BE Studies Conducted at Non-U.S. Sites
Under 21 CFR 320.31(d)(3), persons conducting human BA and BE studies in the United States that are exempt from the IND requirements under part 312 must report any serious adverse events from the study to FDA and to all participating investigators. The requirements under 21 CFR 320.31(d)(3) do not apply to human BA and BE studies that are exempt from the IND requirements and conducted outside of the United States. However, as part of the information required to establish that the proposed drug product can be expected to have the same therapeutic effect as the reference listed product, adverse event information from foreign clinical studies must be included in the abbreviated new drug application (ANDA) submission (see 21 CFR 314.94(a)(7)).
Since this study is a BA/BE Studies Conducted at Non-U.S. Sites IMHO, you need not report the SAE to USFDA in 15 day but it must be included in the abbreviated new drug application (ANDA) submission.
As per schedule Y "Any unexpected serious adverse event (SAE) (as defined in GCP Guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study (see Appendix XI)."
As per Guidance for Industry and Investigators Safety Reporting Requirements for INDs and BA/BE Studies (published December-12)
BA/BE Studies Conducted at Non-U.S. Sites
Under 21 CFR 320.31(d)(3), persons conducting human BA and BE studies in the United States that are exempt from the IND requirements under part 312 must report any serious adverse events from the study to FDA and to all participating investigators. The requirements under 21 CFR 320.31(d)(3) do not apply to human BA and BE studies that are exempt from the IND requirements and conducted outside of the United States. However, as part of the information required to establish that the proposed drug product can be expected to have the same therapeutic effect as the reference listed product, adverse event information from foreign clinical studies must be included in the abbreviated new drug application (ANDA) submission (see 21 CFR 314.94(a)(7)).
Since this study is a BA/BE Studies Conducted at Non-U.S. Sites IMHO, you need not report the SAE to USFDA in 15 day but it must be included in the abbreviated new drug application (ANDA) submission.
—
~A happy Soul~
~A happy Soul~
Complete thread:
- SAE Reporting santosh 2013-01-16 08:02
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- SAE Reporting drgunasakaran1 2013-01-17 04:02
- SAE Reportingluvblooms 2013-01-17 05:49
Ing. Helmut Schütz