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Common Technical Document Quality CTD Q George Wade en

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27 views14 pages

Common Technical Document Quality CTD Q George Wade en

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drpharmachem123
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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The Common Technical Document- Quality

(CTD-Q)

George Wade EMEA


February 2008

with thanks to
Dr. Jean-Louis Robert,
Chairman CHMP/CVMP Quality Working Party
CTD : what is it?

• IT IS :
A common harmonised FORMAT for applications for
preparing marketing authorisations in the three ICH
regions.
a TEMPLATE for presenting data in the dossier.

• IT IS NOT:
A statement of data requirements for applications
CTD : regulatory sources
• Notice to Applicants , Eudralex Vol. 2B : “NTA Guidance”
June 2006 : Structure is defined here.
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-
2/b/ctd_06-2006.pdf

• Q&A Document
http://www.ich.org/LOB/media/MEDIA620.pdf

• ‘Location issues’ ( Quality ) - see CPMP/ICH/4680/02

• ICH Updates
http://www.ich.org
Diagrammatic 1
Regional → not strictly part of CTD
Representation Administrative
Information

Non-clinical Clinical
Overview Overview
Quality
Module 2
Overall Non-clinical Clinical
( Summaries)
Summary Written and Written
Tabulated Summary
2.3 Summaries

3 4 5
Quality Non-clinical Clinical
Study Study
Reports Reports
CTD-Q basic structure
• MODULE 1
Admin and Regional Specific Information
Don’t forget molecular structure aspects re: Similarity (1.7)
- although these are outside the main quality/safety/efficacy
benefit-risk evaluation for an authorisation.
• MODULE 2
CTD Summaries
– Quality Overall Summary (2C) - QOS
• MODULE 3
Main body of Quality Data
i.e. The Q dossier will be basically modules 2.3 & 3
Module 1:
Administrative Regional Information

• 1.1 Table of Contents


• 1.2 Application forms
• 1.3 Product Information, SPC/Labelling/ Package Leaflet
• 1.4.1 Expert declarations & signatures for the QOS
• 1.5 ‘Specific Requirements’ for types of application
bibliographic, generic, biosimilar, informed consent etc.
• 1.6 Environmental Risk Assessment (GMO? )
• 1.7 Orphan issues, structural similarity
• 1.8, 1.9 Pharmacovigilance and Clinical Trials
Module 2: Quality Overall Summary

• This is probably what EU assessors will read first


• Quality Overall Summary
– Written text summary following the outline and scope of the ‘Body
of Data’, Module 3 .
– Not required to be critical
– No formal tabulated summary structure
– Key parameters of the active substance & product which may have
an impact on efficacy or safety should be emphasised
– Relevant tables/figures could be incorporated
– External Drug Master File (ASMF Open part ) will be summarised
here. Closed/Restricted part should be in the ASMF itself.
Module 3: CTD-Q ( guideline )

Note : Same structure for ‘ NCE ’ & ‘ Biotech ’ products


Scope of the guidance , i.e. format
• 3.1 Table of Contents – helpful to assessors
• 3.2 Body of Data ’
• 3.2.S Drug Substance
External Drug Master File ( ASMF ) should also follow this
structure for both the Open and Closed/Restricted parts.
• 3.2.P Drug Product
– 3.2.A Appendices
• A.1 Facilities and equipment ( biotech)
• A.2 Adventitious Agents contamination
• A.3 Excipients ( novel )
Scope

• Addresses the format/structure of applications for MAs of


active substances and their corresponding drug products.
• NTA Guidance : The text following the section titles is intended
to be explanatory and illustrative only i.e. It merely indicates
the location where information has to be provided.
• The actual content of these sections in the dossier should
include relevant information described in existing CHMP- and
CHMP-ICH guidelines
• The section Regional Information addresses information unique
to this region
Example of a ‘network’: Polymorphism
• Cross reference between section P2 (Pharm. Development) and
relevant sections in S (Drug Substance) and in P (Drug Product)

– S 1.3 Properties of the active substance


– S.2 Manufacture
– S 3.1 Studies on Polymorphism (experimental data)
– S 4.1 Specifications relating to control of physical forms
– S.4.3 Analytical methods used
– S 4.5 Justification of Specifications

– P 2: Influence of the polymorphic forms on product


characteristics – dissolution, stability , etc.
– P 5.1 Product Specifications, need to control polymorphs?
– P 5.6 Justification of Specifications
Body of Data – 3.2.A: Appendices

• A 1 Facilities and Equipment:


applies for Biotech. products

• A 2 Adventitious Agents Safety Evaluation:


applies for NCEs and Biotech;
including TSE requirements
viral inactivation studies, etc.
Body of Data 3.2.R : Regional

• Process Validation scheme, manufacture of product


• Medical Devices, if included in the presentation of the
product, CE-mark info. etc.
• Certificates of Suitability , where relevant (e.g. generics ?)
• Materials of animal and/or human origin
issues

• Implementation not equal in all regions?

• Nothing to do with e-CTD ( although the e-CTD is


of course based on the agreed CTD structure )

• In EMEA, for publication purposes (EPARS) we


still prefer to avoid ‘drug’
Drug substance becomes Active Substance

Drug Product becomes Medicinal Product


Conclusions
• Benefit for industry
– Format: yes, better utilisation of global resources
– Content: identical within the 3 regions but can it lead
to an expectation of more data ?
• Benefit for regulators
– Format: yes, easy to evaluate in general
– Content: same as before really, no change.
• Benefit for the patient
– Expedited evaluation is a benefit, especially with a
positive conclusion and early marketing.

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