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ICH Concept Papers & Business Plans

At its meeting in Yokohama, June 2006, the ICH Steering Committee endorsed the publication of finalized Concept Papers and Business Plans* on the ICH web site, for public information.

The Concept Paper is the trigger of all ICH harmonisation activities. This provides a short summary of the proposal. The Business Plan is complementary to the Concept Paper and focuses in particular on regulatory feasibility. The Business Plan outlines the costs and benefits of harmonising the topic proposed by the Concept Paper.
(Read more on Concept Papers and Business Plans in the Process for Harmonisation section).

 

Concept Papers for all Quality, Safety, Efficacy and Multidisciplinary topics can be found below:

 

Quality Topics 
Concept Papers
Safety Topics 
Concept Papers
Efficacy Topics 
Concept Papers
Multidisciplinary Topics
Concept Papers

 

The Concept Papers of the topics currently going through the ICH Process for Harmonisation are available below :

 

Current Topics

Code

 

Q3D

Q3D Final Concept Paper
Impurities: Guideline for Metal Impurities
Dated 17 July 2009
Endorsed by the Steering Committee on 29 October 2009

 Q3D Final Business Plan

Q3C(R5)

Q3C(R5) Final Concept Paper

Impurities: Guideline for Residual Solvents 
Revision of the Q3C(R4) to account for new toxicity data related to cumene

Dated 20 August 2009

Endorsed by the Steering Committee on 10 June 2009

No Business Plan is required for Guideline revisions.

Q11

  Q11 Final Concept Paper

Development and Manufacture of Drug Substances
(chemical entities and biotechnological/biological entities), 

Dated 11 April 2008

Endorsed by the Steering Committee on 11 April 2008

  Q11 Final Business Plan

Quality
Implementation

  Quality Implementation Final Concept Paper

on ICH Q8, Q9 and Q10, 

Dated and Endorsed by the Steering Committee on 1 November 2007

Q8

  Q8 Final Concept Paper

Pharmaceutical Development, 

Dated 19 September 2003

Endorsed by the Steering Committee on 8 October 2003

S2(R1)

  S2(R1) Final Concept Paper
Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use
(Revision of the Guidelines: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals (S2A), and
Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals (S2B))

Dated 14 September 2006

Endorsed by the Steering Committee on 20 September 2006

No Business Plan is required for Guideline revisions.

S6(R1)

  S6(R1) Final Concept Paper

Revision of the S6 Guideline:  

Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
Dated 19 June 2008
Endorsed by the Steering Committee on 4 June 2008.

No Business Plan is required for Guideline revisions.

E2B(R3)

  E2B(R3) Final Concept Paper

Revision of the E2B(M) ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports, 

Dated 10 November 2003

Endorsed by the Steering Committee on 11 November 2003

No Business Plan is required for Guideline revisions.

E2F

  E2F Final Concept Paper

Development Safety Update Report, 

Dated 7 September 2006
Endorsed by the Steering Committee on 20 September 2006

  E2F Final Business Plan

E7(R1)

  E7(R1) Final Concept Paper
Studies in Support of Special Populations: Geriatrics, 
Dated 23 October 2008
Endorsed by the Steering Committee on 24 September 2008
No Business Plan is required for Guideline revisions

E16

  E16 Final Concept Paper
Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions, 
Dated 17 April 2008
Endorsed by the Steering Committee on 11 April 2008
  E16 Final Business Plan

M2/eCTD
CTD-QUALITY

CTD-Q Final Concept Paper
CTD-Quality-Related Questions and Change Requests raised by eCTD
Dated 3 Sept 2007
Endorsed by the Steering Committee on 7 September 2007

M3(R2)

  M3(R2) Final Concept Paper
Revision of the M3(R1) Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals,
dated 7 September 2006
Endorsed by the Steering Committee on 20 September 2006

No Business Plan is required for Guideline revisions.

M5

  M5 Final Concept Paper

Data Elements and Standards for Drug Dictionaries, 

Dated and endorsed by the Steering Committee on 9 June 2004
  M5 Final Business Plan

M6

  Gene Therapy Final Concept Paper

Guideline on Virus and Gene Therapy Vector Shedding and Transmission 

Dated and endorsed by the Steering Committee on 18 September 2009
  Appendix I: ICH Considerations on Viral/Vector Shedding

Appendix II: Final Concept Paper on Viral/Vector Shedding

  Appendix II: E.A.M Schenk-Braat et al. An inventory of shedding data from clinical gene therapy trials. JGeneMed 2007; 9:910-921.

  Gene Therapy  Final Business Plan

 

* The Business Plans were made mandatory to the new ICH Topics Concept Papers since June 2004.
   No Business Plan is required for Guideline revisions.
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