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Trials. Please adapt it as necessary for your work, and reference Global
Health Trials when possible when using this document.
SOP Ref No
SOP
SOP title
Category
Clinical
Version
1.0
Date issued
Valid until
(maximum of 2 years)
Author(s)
Name:
Signature:
Approved by
Date:
Name:
Signature
Date
Modification history
Version No
Date
Author(s)
Date reissued to
previous recipients
1.0
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Page 1 of 8
This template document has been made freely available by Global Health
Trials. Please adapt it as necessary for your work, and reference Global
Health Trials when possible when using this document.
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Page 2 of 8
This template document has been made freely available by Global Health
Trials. Please adapt it as necessary for your work, and reference Global
Health Trials when possible when using this document.
2. Type of IMPD
EU guidance allows for less detailed information to be provided in certain
situations1.
Full IMPD required when similar information has not been previously
provided to the MHRA (or equivalent in another EU member state) for a CTA
application or request for Marketing Authorisation.
Simplified IMPD if this information has been provided previously
SmPC for products with a Marketing Authorisation in an EU member state,
the Summary of Product Characteristics (SmPC) may be provided instead of
an IMPD as long as the product is being used for the same indication and in
accordance with the marketing authorisation.
3. Format of information
3.1 Full IMPD. The sections of the IMPD should follow the structure
described in the EU guidance document ENTR/CT1 on pages 21241,
included as an appendix to this SOP.
3.2 Simplified IMPD. If the product has a previous CTA, then information on
quality data, clinical data and non-clinical data does not need to be
resubmitted. A cross reference to the previous application can be made. If
there is new data since the previous CTA was granted, this should be
submitted. See ENTR/CT1 for further details1.
4. Updating
IMPDs should be updated on a yearly basis. Changes are most likely to be
needed where more data from clinical trials has become available. All changes
to the document must be recorded on an amendments page at the front of the
document detailing the date and nature of the change. A new version number
must be assigned to the document with each significant change.
5. References
1. Detailed guidance for the request for authorisation of a clinical trial on a
medicinal product for human use to the competent authorities, notification
of substantial amendments and declaration of the end of the trial, EU
guidance document ENTR/CT1 Revision 1, April 2004 http://eudract.emea.eu.int/docs/Detailed%20guidance%20EudraCT.pdf.
2. Guideline for good clinical practice - ICH Harmonised Tripartite
Guideline, 1996 - http://www.ich.org/MediaServer.jser?
@_ID=482&@_MODE=GLB. EU version: CPMP/ICH/135/95 http://pharmacos.eudra.org/F2/eudralex/vol-3/pdfs-en/3cc1aen.pdf
6. Appendix
Pages 2124 of ENTR/CT1: format of IMPD.
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This template document has been made freely available by Global Health
Trials. Please adapt it as necessary for your work, and reference Global
Health Trials when possible when using this document.
21
This template document has been made freely available by Global Health
Trials. Please adapt it as necessary for your work, and reference Global
Health Trials when possible when using this document.
22
This template document has been made freely available by Global Health
Trials. Please adapt it as necessary for your work, and reference Global
Health Trials when possible when using this document.
23
This template document has been made freely available by Global Health
Trials. Please adapt it as necessary for your work, and reference Global
Health Trials when possible when using this document.
24