Biologics Consulting Group, Inc.

ICH Documents

Our collection of International Conference on Harmonisation (ICH) documents is collected from the ICH web site and so represents the version issued by the ICH rather than the version issued by the FDA. To view the version issued by the FDA, click on the FDA Release Date at the far right. Our listing is organized into a single table and is listed by category and by ICH Document Number. Clicking the ICH document number will take you to the .pdf file. To save a copy of the document for yourself, click on the link with your right mouse button (Windows, OS/2, Linux, and Solaris) or click and hold the single mouse button (Mac) to display the context menu. Select "Save Link As...", select the appropriate location (folder) and press "Save." You can find additional ICH Documents on the ICH web site.

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ICH DOCUMENTS

E = Efficacy Topics; M = Multidisciplinary Topics; Q = Quality Topics; S = Safety Topics

Date Issued	ICH #	Title	Step	Pages	FDA Release Date
EFFICACY TOPICS:
27 October 1994	E1	The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term-Treatment of Non-Life-Threatening Conditions	5	5	1 March 1995
27 October 1994	E2A	Clinical Safety Data Management: Definitions and Standards for Expedited Reporting	5	12	1 March 1995
12 May 2005	E2B(R3)	Revision of the ICH Guideline on Clinical Safety Data Management - Data Elements for Transmission of Individual Case Safety Reports (previously coded E2B(M))	3	32	12 May 2005 revision 2
3 March 2005	E2B(R5)	E2B Implementation Working Group Questions & Answers (R5)	5	22	16 March 2005
17 July 1997	E2B(M)	Maintenance of the ICH Guideline on Clinical Safety Data Management: Data Elements for Transmissions of Individual Case Safety Reports (Amended for Maintenance on 10 November 2000)	4	29	4 April 2002
3 March 2005	E2B(M) Q&A	Implementation Working Group Questions & Answers (Version 1.1)		21	9 March 2005 Revision 2
6 November 1996	E2C (R1)	Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs (previously coded E2C)	4	22	November 1996
6 February 2003	E2C (R1) Addendum	Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs - Addendum implemented into core guideline in ICH version Nov. 2005	5	11	4 February 2004
12 November 2003	E2D	Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting	5	15	.
18 November 2004	E2E	Pharmacovigilance Planning (PvP)	5	20	31 March 2005
5 June 2008	E2F	Development Safety Update Report	3	29	5 August 2008
30 November 1995	E3	Structure and Content of Clinical Study Reports	5	50	17 July 1996
10 March 1994	E4	Dose Response Information to Support Drug Registration	5	13	9 November 1994
20 November 2003	E5 Q&A (R1)	Ethnic Factors in the Acceptability of Foreign Clinical Data - Questions and Answers	5	6	28 September 2006.
5 February 1998	E5 (R1)	Ethnic Factors in the Acceptability of Foreign Clinical Data (previously coded E5)	5	17	10 June 1998
1 May 1996	E6 (R1)	Guideline for Good Clinical Practice (previously coded E6)	4	57	April 1996
24 June 1993	E7	Studies in Support of Special Populations: Geriatrics	5	6	2 August 1994
17 July 1997	E8	General Considerations for Clinical Trials	5	15	17 December 1997
5 February 1998	E9	Statistical Principles for Clinical Trials	5	39	16 September 1998
20 July 2000	E10	Choice of Control Group in Clinical Trials	5	35	11 May 2001
20 July 2000	E11	Clinical Investigation of Medicinal Products in the Pediatric Population	5	16	15 December 2000
2 March 2000	E12A	Principles for Clinical Evaluation of New Antihypertensive Drugs (previously coded E12A)	5	10	9 August 2000
12 May 2005	E14	The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs	5	18	20 October 2005
1 November 2007	E15	Terminology in Pharmacogenomics	4	10	.
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MULTIDISCIPLINARY TOPICS:
	M2	Electronic Standards for Transmission of Regulatory Information (ESTRI)			1 April 2003
		M2: eCTD Specification; Questions & Answers and Change Requests Companion Doc			March 2005 March 2005 July 2005
	M3	Timing of Pre-clinical Studies in Relation to Clinical Trials			.
13 January 2004	M4R3	Organisation of The CTD for the Registration of Pharmaceuticals for Human Use	5	16	October 2005
10 June 2004	M4 Q&A	The CTD -- General: Questions and Answers R3	5	9	Revision 2 May 2004 Revision 3 22 December 2004.
9 November 2000	M4E	The CTD - Efficacy	4	53	16 October 2001
10 June 2004	M4E Q&A	The CTD - Efficacy Questions and Answers	5	7	Revision 3 22 December 2004
20 December 2002	M4S(R2)	The CTD - Safety	5	115	16 October 2001 Safety Appendices 16 October 2001
11 November 2003	M4S Q&A	The CTD - Safety Questions and Answers	5	3	3 February 2003
12 September 2002	M4Q(R1)	The CTD - Quality	5	24	16 October 2001
17 July 2003	M4Q Location Q&A	The CTD Quality: Questions and Answers/Location Issues	4	27	8 June 2004
10 May 2005	M5	Data Elements and Standards for Drug Dictionaries	2	33
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QUALITY TOPICS:Blank
Stability:lank
27 October 1993	Q1A	Stability Testing of New Drug Substances and Products		15
6 February 2003	Q1A(R2)	Stability Testing of New Drug Substances and Products (Revised guideline)	5	19	20 November 2003
6 November 1996	Q1B	Stability Testing: Photostability Testing of New Drug Substances and Products	5	12	16 May 1997
6 November 1996	Q1C	Stability Testing for New Dosage Forms Annex to the ICH Harmonized Tripartite Guidelines on Stability Testing for New Drugs and Products	5	3	.
7 February 2002	Q1D	Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products	5	11	15 January 2003
6 February 2003	Q1E	Evaluation for Stability Data	5	19	. 7 June 2004
6 February 2003	Q1F	Stability Data Package for Registration Applications in Climatic Zones III and IV	5	8	2 July 2004
Validation of Analytical Procedures:
27 October 1994	Q2A	Text on Validations of Analytical Procedures	5	7	.
6 November 1996	Q2B	Validation of Analytical Procedures: Methodology	5	12	.
Impurity Testing:
30 March 1995	Q3A	Impurities in New Drug Substances	5	14	11 February 2003
7 February 2002	Q3A(R)	Impurities in New Drug Substances (Revised Guideline)	5	15	.
6 November 1996	Q3B	Impurities in New Drug Products	5	12	.
5 February 2003	Q3B(R)	Impurities in New Drug Products (Revised Guideline)	5	15	13 November 2003
17 July 1997	Q3C	Impurities: Guideline for Residual Solvents	5	20	Tables and Lists 12 November 2003 Residual Solvents 24 December 1997
12 September 2002	Q3C(M)	Impurities : Residual Solvents (Maintenance) PDE for Tetrahydrofuran	5	4	.
12 September 2002	Q3C(M)	Impurities : Residual Solvents (Maintenance) PDE for N-Methylpyrrolidone (NMP)	5	4	..
Quality of Biotechnological Products:
5 March 1997	Q5A	Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin	5	32	24 September 1998
30 November 1995	Q5B	Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of R-DNA Derived Protein Products	5	6	. .
30 November 1995	Q5C	Quality of Biotechnological Products: Stability Testing to Biotechnological/Biological Products	5	10	10 July 1996
16 July 1997	Q5D	Deviation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products	5	17	21 September 1998
18 November 2004	Q5E	Comparability of Biotechnologies/Biological Products Subject to Changes in Their Manufacturing Process	5	16	29 June 2005
Specifications for New Drug Substances and Products:
6 October 1999	Q6A	Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances	5	24	29 December 2000
November 1999	Q6A	Decision Tree	5	11
10 March 1999	Q6B	Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products	5	20	18 August 1999
GMP for Pharmaceutical Ingredients:
10 November 2000	Q7A	Good Manufacturing Practices for Active Pharmaceutical Ingredients	5	49	25 September 2001
18 November 2004	Q8	Draft Guidance on Pharmaceutical Development	3	12	8 February 2005
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SAFETY TOPICS:
29 November 1995	S1A	Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals	5	8	March 1996
16 July 1997	S1B	Testing for Carcinogenicity in Pharmaceuticals	5	9	.
27 October 1994	S1C	Dose Selection for Carcinogenicity Studies of Pharmaceuticals	5	10	.
17 July 1997	S1C(R)	Addendum to "Dose Selection for Carcinogenicity Studies of Pharmaceuticals" Addition of a Limit Dose and Related Notes	5	2	.
19 July 1995	S2A	Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals	5	15	.
16 July 1997	S2B	Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals	5	12	.
27 October 1994	S3A	Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies	5	14	.
27 October 1994	S3B	Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies	5	4	.
2 September 1998	S4A	Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicology Testing)	5	4	25 June 1999
24 June 1993	S5A	Detection of Toxicity to Reproduction for Medicinal Products	5	20	.
29 November 1995	S5B(M)	Maintenance of the ICH Guideline on Toxicity to Male Fertility An Addendum to the ICH Tripartite Guideline on Detection of Toxicity to Reproduction for Medicinal Products	5	6
16 July 1997	S6	Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals	4	13	.
8 November 2000	S7A	Safety Pharmacology Studies for Human Pharmaceuticals	4	13	12 July 2001
10 June 2004	S7B	The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals	3	13	10 September 2004
18 November 2004	S8	Draft Consensus Guideline: Immunotoxicity Studies for Human Pharmaceuticals	3	15	7 February 2005
9 November 2000	M3(M)	Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals	5	9	.