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Dear members,
We conducted a two period cross-over bioequivalence study. Reference
tablet is manufactured by a European Pharmaceutical company for US
Pharmaceutical company. The reference medicine is being marketed in
US. One of the subject experienced Serious Adverse Event after taking
test medicine during period one. Doctors predict that SAE is an
adverse drug reaction. The test medicine is manufactured by an Indian
Pharmaceutical company. After treatment the subject recovered. The
case is informed to Institutional Review Board. Is it required to
inform to regulatory bodies? If yes, to which regulatory bodies
( i.e. European / US / India) we need to inform?
Regards,
Sumanta
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The following message was posted to: PharmPK
Dear Sumanta,
As per my understanding, any SAE that occurs during a clinical study has
to be informed to the concerned Local Regulatory Agency. In this case,
it is our DCGI. But again as per the GCP and schedule Y, Investigator
should inform the IEC and the sponsor as early as possible (preferably
within 24 hrs) and it is the Sponsor who has to convey the information
to the regulatory agency as per their SOP (within 14 calendar days). So,
check with your sponsor about the same.
Hope, I have given some useful information.
Regards,
Dr. M. Joseph
Principal Investigator,
GVK Bio.
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I believe, you should inform to the NDRA of country from where Test
product
procured. Also, you have to inform the NDRA of country where the
study is
going on.
Rakesh Chaurasia
Mumbai-India
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The following message was posted to: PharmPK
Dear Sumanta,
It is dependent on the country where the study was conducted. If it
was in
India, your obligation is to report ADR to Indian reguletory
authority only
if ADR was unexpected. More information on this subject you can find
on the
website of the the International Conference on Harmonisation (ICH):
http://www.ich.org
The document is Clinical Safety Data Management: Definitions and
Standards
for Expedited Reporting
Regards,
Ivan Kovacevic
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The following message was posted to: PharmPK
Dear Sumanta,
I had an oppurtunity to discuss this issue with the
experties few days back and the answer delivered is exactly
the same as explained by Dr M Joseph.
Regards,
Dr Suhas
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