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Dear All:
2 questions please.
1 . Are GCP Guidelines country - specific ?. I understand that there
is an Indian GCP and if so, what is the purpose of ' harmonization'?
Has 'H" in ICH been unsuccessful?
2. What is the relationship between Indian GCP and Schedule Y
( 2005)?. I understand that Schedule Y ( 2005) is the Appendix 2 to
Indian GCP, and both Indian GCP and Schedule Y discuss the ways and
means of conduct of clinical trials? But, why two documents?
I shall be grateful for your expert comments, please.
Regards
Ram
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The following message was posted to: PharmPK
Dear Ram!
> 1 . Are GCP Guidelines country - specific ?. I understand that there
> is an Indian GCP and if so, what is the purpose of ' harmonization'?
> Has 'H" in ICH been unsuccessful?
To quote the welcome page of http://www.ich.org:
The International Conference on Harmonisation of Technical
Requirements for
Registration of Pharmaceuticals for Human Use (ICH) is a unique
project that
brings together the regulatory authorities of *Europe*, *Japan* and
the *United
States* and experts from the pharmaceutical industry in the *three
regions* to
discuss scientific and technical aspects of product registration.
....'H' was very successful in the three ICH-regions.
Other countries have developed and adopted their own set of GCPs.
For a comparison of documents see:
http://bebac.at/Guidelines.htm
> 2. What is the relationship between Indian GCP and Schedule Y
> ( 2005)?. I understand that Schedule Y ( 2005) is the Appendix 2 to
> Indian GCP, and both Indian GCP and Schedule Y discuss the ways and
> means of conduct of clinical trials? But, why two documents?
>
http://www.cdsco.nic.in/html/Schedule-Y%20(Amended%20Version-2005)%20original.htm
http://www.cdsco.nic.in/html/GCP1.html
I leave the explanation to our Indian collegues... ;-)
Best regards,
Helmut
--
Ing. Helmut SchA\0x00tz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
e-mail helmut.schuetz.-at-.bebac.at
web http://bebac.at
contact http://bebac.at/Contact.htm
forum http://forum.bebac.at
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The following message was posted to: PharmPK
dear,
the ICH GCP is world wide acceptable practice as this leads to ICH
regions, in addition with each and every country has its own guideline
of GCP which is nothing but on the basis of ICH GCP, declaration of
helsinki, so while reporting or following the ICH GCP which indirectly
compliance of national rules and regulation.
but for the submittion purpose of DCGI in india need to be follow the
indian GCP, ex.all staff need to be train on that and compliance
statement should be adhere with the compliance for the same.
hope answer can near about your concern, expert can comment.
regards
p
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The following message was posted to: PharmPK
dear,
the ICH GCP is world wide acceptable practice as this leads to ICH
regions, in addition with each and every country has its own guideline
of GCP which is nothing but on the basis of ICH GCP, declaration of
helsinki, so while reporting or following the ICH GCP which indirectly
compliance of national rules and regulation.
but for the submittion purpose of DCGI in india need to be follow the
indian GCP, ex.all staff need to be train on that and compliance
statement should be adhere with the compliance for the same.
hope answer can near about your concern, expert can comment.
regards
p
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Hi,
On relationship between Schedule Y & Indian GCP
In Indian context, the Schedule Y has its origin from the Drugs &
Cosmetics Act and thus has the status of legally enforceable
provision. The Indian GCP is more like a "Best Practice" guiding
document. I think this is similar to the CFR provisions (e.g. 21, 56
etc) and the ICH/ FDA guidance in the US context.
Regards,
- Pankaj
--
Pankaj Goyal, M.D.
Principal Scientist- Clinical Development
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