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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 |
Impurities: Guideline for Metal Impurities Dated 17 July 2009 Endorsed by the Steering Committee on 29 October 2009 |
Q3C(R5) |
Impurities:
Guideline for Residual Solvents Dated 20 August 2009 Endorsed by the Steering Committee on 10 June 2009 No Business Plan is required for Guideline revisions. |
Q11 |
Development
and Manufacture of Drug Substances Dated 11 April 2008 Endorsed by the Steering Committee on 11 April 2008 |
Quality
|
on ICH Q8, Q9 and Q10, Dated and Endorsed by the Steering Committee on 1 November 2007 |
Q8 |
Pharmaceutical Development, Dated 19 September 2003 Endorsed by the Steering Committee on 8 October 2003 |
S2(R1) |
Endorsed by the Steering Committee on 20 September 2006 No Business Plan is required for Guideline revisions. |
S6(R1) |
Revision of the S6 Guideline: Preclinical
Safety Evaluation of Biotechnology-Derived Pharmaceuticals No Business Plan is required for Guideline revisions. |
E2B(R3) |
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 |
Development Safety Update Report, Dated
7 September 2006 |
E7(R1) |
|
E16 |
|
M2/eCTD
|
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) |
No Business Plan is required for Guideline revisions. |
M5 |
Data Elements and Standards for Drug Dictionaries, Dated
and endorsed by the Steering Committee on 9
June 2004 |
M6 |
Guideline on Virus and Gene Therapy Vector Shedding and Transmission Dated
and endorsed by the Steering Committee on 18 September 2009 |
* 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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