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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

New codification system

 

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

Q10

  Q10 Final Concept Paper

Pharmaceutical Quality Systems, 

Dated 9 September 2005

Endorsed by the Steering Committee on 10 November 2005

  Q10 Final Business Plan

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.

S9

  S9 Final Concept Paper
Preclinical Guideline on Oncology Therapeutic Development
Dated 30 April 2007
Endorsed by the Steering Committee on 10 May 2007.

  S9 Final Business Plan

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

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

 

* 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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