New Codification as per November 2005 (Click here for more details)

Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)

This guideline has been revised a second time in order to accommodate for the consequences of Q1F and has reached Step 4 of the ICH process on 6 February 2003. 

This guideline provides recommendations on stability testing protocols including temperature, humidity and trial duration. Furthermore, the revised document takes into account the requirements for stability testing in Climatic Zones III and IV in order to minimize the different storage conditions for submission of a global dossier.

EU : Adopted by CPMP, March 2003, issued as CPMP/ICH/2736/99
MHLW : Adopted June 3, 2003, PFSB/ELD Notification No. 0603001
FDA : Published in the Federal Register, Vol, 68, No. 225, Friday, November 21, 2003; pages 65717-18

Q1B: Photostability Testing of New Drug Substances and Products

The tripartite harmonised ICH guideline was finalised (Step 4) in November 1996. This forms an annex to the main stability guideline, and give guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.

EU: Adopted by CPMP, December 96, issued as CPMP/ICH/279/95
MHLW: Adopted May 97, PAB/PCD Notification No.422
FDA: Published in the Federal Register, Vol. 62, No. 95, May 16, 1997, pages 27115-27122. 

Q1C: Stability Testing for New Dosage Forms

The tripartite harmonised ICH guideline was finalised (Step 4) in November 1996. It extends the main stability guideline for new formulations of already approved medicines and defines the circumstances under which reduced stability data can be accepted.

EU: Adopted by CPMP, December 96, issued as CPMP/ICH/280/95
MHLW: Adopted May 97, PAB/PCD Notification No.425
FDA: Published in the Federal Register, Vol. 62, No. 90, May 9, 1997, pages 25634-25635 

Q1D, Q1E, Q1F

The ICH Steering Committee agreed that the main stability guideline should be complemented by the following topics : Matrixing and Bracketing (Q1D), Statistical Analysis and Interpretation of Data (Q1E), Data Package for Registration in Climatic Zones III and IV (Q1F)

Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products

The tripartite harmonised ICH guideline was finalised (Step 4) in February 2002. This document describes general principles for reduced stability testing and provides examples of bracketing and matrixing designs.

EU: Adopted by CPMP, Februar 2002, CPMP/ICH/4104/00
MHLW: Adopted on July 31, 2002 as PFSB/ELD Notification No. 0731004
FDA: Published in the Federal Register, Vol 68, No. 11; January 16, 2003; pages 2339-2340

Q1E: Evaluation of Stability Data

The tripartite harmonised ICH guideline was finalised (Step 4) in February 2003. This document extends the main guideline by explaining possible situations where extrapolation of retest periods/shelf-lives beyond the real-time data may be appropriate. Furthermore, it provides examples of statistical approaches to stability data analysis.

EU: Adopted by CPMP, March 2003, issued as CPMP/ICH/420/02
MHLW: Adopted June 3, 2003, PFSB/ELD Notification No. 0603004
FDA: Published in the Federal Register / Vol. 69, N° 110, Tuesday June 8, 2004, pages 32010-32011

Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV

  The ICH Steering Committee endorsed the withdrawal of the Q1F guideline at its meeting in Yokohama, June 2006

 Click here to open the Explanatory Note

Guideline withdrawn on June 8, 2006

EU: Withdrawal notification and Explanatory Note, issued as CPMP/ICH/421/02, June 2006
MHLW: Withdrawal adopted 3rd July 2006, PFSB/ELD Notification n° 0703001
FDA: Withdrawn from CDER's guidance page on 7/6/2006 and will be listed in the next FDA annual guidance agenda published in the Federal Register.

Q2(R1): Validation of Analytical Procedures: Text and Methodology

The core tripartite harmonised ICH text (previously coded Q2A) was finalised (Step 4) in October 1994. This identifies the validation parameters needed for a variety of analytical methods. It also discusses the characteristics that must be considered during the validation of the analytical procedures which are included as part of registration applications.

The addendum tripartite harmonised ICH text (previously coded Q2B) was finalised (Step 4) in November 1996. It extends the guideline Q2A to include the actual experimental data required, along with the statistical interpretation, for the validation of analytical procedures.

The addendum has been incorporated into the core guideline in November 2005.

EU: Adopted by CPMP, November 94, issued as CPMP/ICH/381/95
MHLW: Adopted July 95, PAB/PCD Notification No.755
FDA: Published in the Federal Register, Vol. 60, March 1, 1995, pages 11260

EU: Adopted by CPMP, December 96, issued as CPMP/ICH281/95
MHLW: Adopted October 97, PMSB/ELD Notification No.338
FDA: Published in the Federal Register, Vol. 62, No. 96, May 19, 1997, pages 27463-27467

Q3A(R2): Impurities in New Drug Substances (Revised Guideline)

First Recommended for Adoption at Step 4 of the ICH Process on 30 March 1995, the guideline was revised under Step 2 of the ICH Process on 7 October 1999 and Recommended for Adoption under Step 4 on 7 February 2002 by the ICH Steering Committee. 

The guideline addresses the chemistry and safety aspects of impurities, including the listing of impurities in specifications and defines the thresholds for reporting, identification and qualification. The revision of the guideline has allowed clarifying some inconsistencies, to revise the decision tree, to harmonize with Q3B and to address some editorial issues.

  The Attachment 2 of this guideline has been revised under Step 4 without further public consultation on 25 October 2006.

EU: Adopted by CPMP, February 2002, CPMP/ICH/2737/99 (Revision of CPMP/ICH/142/95) Revised Attachment 2 adopted by CPMP October 2006.
MHLW: Adopted on 16 December 2002, Notification ELD n° 1216001 Revision of Attachment 2 Adopted December 4, 2006, PFSB/ELD Notification No. 1204001
FDA: Published in the Federal Register, Vol, 68, No. 68, Tuesday February 11, 2003; p. 6924-6925 Revision of Attachment 2 to be notified

Q3B(R2): Impurities in New Drug Products (Revised Guideline)

This guideline has been revised and finalised under Step 4 in February 2003. It complements the guideline on impurities in new drug substances and provides advice in regard to impurities in products containing new, chemically synthesized drug substances. The guideline specifically deals with those impurities which might arise as degradation products of the drug substance or arising from interactions between drug substance and excipients or components of primary packaging materials. The guideline sets out a rationale for the reporting, identification and qualification of such impurities based on a scientific appraisal of likely and actual impurities observed, and of the safety implications, following the principles elaborated in the parent guideline. Threshold values for reporting and control of impurities are proposed, based on the maximum daily dose of the drug substance administered in the product.
Q3B Final Concept Paper, March 1994

  The Attachment 2 of this guideline has been revised under Step 4 without further public consultation on 2 June 2006.

EU: Adopted by CPMP, March 2003, issued as CPMP/ICH/2738/99; Revised Attachment 2 Adopted by CPMP, June 2006, CPMP/ICH/2738/99
MHLW: Adopted on 24 June 2003, PFSB/ELD Notification n° 0624001; Revised Attachment 2 Adopted 3rd July 2006, PFSB/ELD Notification N° 0703004.
FDA: Published in the Federal Register, Vol, 68, No. 220, Friday November 14, 2003; p. 64628-64629
with the Revised Attachment 2.

Q3C(R3): Impurities: Guideline for Residual Solvents 

The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products.

Q3C Final Concept Paper, March 1994

Impurities: Guideline for Residual Solvents (Maintenance)

A Maintenance process has been done to revise PDEs, as new toxicological data for solvents becomes available. 

The two documents have reached Step 4 of the process in September 2002.

Limit values for two residual solvents in drug products were revised on basis of the newly recognized toxicity data; lower PDE (permissible daily exposure) for N-Methylpyrrolidone being kept in Class 2 (limited by health-basis) and for Tetrahydrofuran being placed into Class 2 from Class 3 (no health-based).

Both revisions (PDE for THF and PDE for NMP) have been incorporated into the core Guideline in November 2005.

EU: Adopted by CPMP, September 97, issued as CPMP/ICH/283/95
MHLW: Adopted March 1998, PMSB/ELD Notification No.307
FDA: Published in the Federal Register, Vol. 62, No. 247, December 24, 1997, page 67377
Q3C Tables and List [Word] or [PDF]  (Posted 11/12/2003); published in FR, Vol.68, No. 219, Thursday, November 13, 2003; pages 64352-64353

(Incorporated into the core guideline)

EU: Adopted by CPMP, September 2002, issued as CPMP/ICH/1940/00
MHLW: Adopted 25 December 2002, Notification ELD N° 1225006
FDA: The revised PDE is reflected in the Q3C Tables and List [Word] or [PDF]  (Posted 11/12/2003); published in FR, Vol.68, No. 219, Thursday, November 13, 2003; pages 64352-64353

EU: Adopted by CPMP, September 2002, issued as CPMP/ICH/1940/00
MHLW: Adopted 25 December 2002, Notification ELD N° 1225006
FDA: The revised PDE is reflected in the Q3C Tables and List [Word] or [PDF]  (Posted 11/12/2003); published in FR, Vol.68, No. 219, Thursday, November 13, 2003; pages 64352-64353

Q4: Pharmacopoeias

Q6A activity provided the framework on how to set specifications for drug substances to address how regulators and manufacturers might avoid setting or agreeing to conflicting standards for the same product, as part of the registration in different regions.  The resulting ICH Q6A Guideline provides harmonised guidance in this area.  With the passage of the Chemical Substances (Q6A) ICH Guideline, the harmonisation of about 10 compendial test chapters has been considered as critical by the ICH Steering Committee.  These chapters are at various stages of harmonisation among the three pharmacopeial organisations (USP, JP & EP). The three organisations conduct their harmonisation efforts through a tripartite pharmacopeial harmonisation program known as the Pharmacopoeial Discussion Group (PDG).

Q4A: Pharmacopoeial Harmonisation

The Pharmacopoeial authorities, working together through the Pharmacopoeial Discussion Group (PDG), have been closely involved with the work of ICH since the outset and harmonisation between the major Pharmacopoeias, which started before ICH, has proceeded in parallel. The ICH Steering Committee receives regular reports on the status of pharmacopoeial harmonisation at its meetings.

Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

The tripartite harmonised ICH guideline was finalised (Step 4) on 1 November 2007. 
This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favourable evaluations, ICH will issue topic-specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry.

Given the nature of this topic, no Concept Paper was developed for Q4B.

EU: Adopted by CHMP December 2007, issued as EMEA/CHMP/ICH/222007/2006. Date for coming into operation : June 2008.
MHLW: To be notified
FDA: Published in the Federal Register, 21 February 2008, Vol. 73, N° 35, pages 9575-9576

Q4B Annex 1: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Residue on Ignition/Sulphated Ash General Chapter

The tripartite harmonised ICH guideline was finalised (Step 4) on 1 November 2007. 
This annex is the result of the Q4B process for Residue on Ignition/Sulphated Ash. 
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

EU: Adopted by CHMP December 2007, issued as EMEA/CHMP/ICH/222063/2006. Date for coming into operation: June 2008.
MHLW: To be notified
FDA: Published in the Federal Register, 21 February 2008, Vol. 73, N° 35, pages 9576-9577

Q4B Annex 2: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Test for Extractable Volume of Parenteral Preparations General Chapter

The tripartite harmonised ICH guideline was finalised (Step 4) on 5 June 2008.
This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. 
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

EU: To be notified
MHLW: To be notified
FDA: To be notified

Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Test for Particulate Contamination: Sub-Visible Particles General Chapter

The tripartite harmonised ICH guideline was finalised (Step 4) on 5 June 2008.
This annex is the result of the Q4B process for Test for Particulate Contamination: Sub-Visible Particles. 
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

EU: Final approval by CHMP June 2008, date for coming into operation : December 2008. Issued as EMEA/CHMP/ICH/561176/2007
MHLW: To be notified
FDA: To be notified

Q4B Annex 4A: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Microbiological Examination of Non-Sterile Products:
Microbial Enumeration Tests General Chapter

This guideline has been released for consultation under Step 2 of the ICH process on 5 June 2008.
This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. 
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

EU: Transmission to CHMP and Interested Parties in June 2008. Deadline for comments: September 2008. Issued as EMEA/CHMP/ICH/308671/2008.
MHLW: Released for consultation in August 2008, deadline for comments by October 10, 2008.
FDA: Published in the Federal Register, Vol. 73, No. 151, August 5, 2008. Deadline for comments by October  6, 2008.

Q4B Annex 4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Microbiological Examination of Non-Sterile Products:
Tests for Specified Micro-organisms General Chapter

This guideline has been released for consultation under Step 2 of the ICH process on 5 June 2008.
This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-organisms. 
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

EU: Transmission to CHMP and Interested Parties in June 2008. Deadline for comments: September 2008. Issued as EMEA/CHMP/ICH/308817/2008.
MHLW: Released for consultation in August 2008, deadline for comments by October 10, 2008.
FDA: Published in the Federal Register, Vol. 73, No. 151, August 5, 2008. Deadline for comments by October 6, 2008.

Q4B Annex 4C: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Microbiological Examination of Non-Sterile Products:
Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter

This guideline has been released for consultation under Step 2 of the ICH process on 5 June 2008.
This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use. 
For each regulatory region the pharmacopoeial text is non-mandatory and is provided for informational purposes only.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

EU: Transmission to CHMP and Interested Parties in June 2008. Deadline for comments : September 2008. Issued as EMEA/CHMP/ICH/308867/2008.
MHLW: Released for consultation in August 2008, deadline for comments by October 10, 2008.
FDA: Published in the Federal Register, Vol. 73, No. 151, August 5, 2008. Deadline for comments by October 6, 2008.

Q4B Annex 5: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on
Disintegration Test General Chapter

This guideline has been released for consultation under Step 2 of the ICH process on 5 June 2008.
This annex is the result of the Q4B process for Disintegration Test General Chapter.
The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG).

EU: Transmission to CHMP and Interested Parties in June 2008. Deadline for comments: September 2008. Issued as EMEA/CHMP/ICH/308895/2008.
MHLW: Released for consultation in August 2008, deadline for comments by October 10, 2008.
FDA: Published in the Federal Register, Vol. 73, No. 151, August 5, 2008. Deadline for comments by October 6, 2008.

Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

The tripartite harmonised ICH guideline was finalised (Step 4) in March 1997. This is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. The purpose is to provide a general framework for virus testing experiments for the evaluation of virus clearance and the design of viral tests and clearance evaluation studies. 
(Please note that a typographic error has been corrected (Sept. 23, 1999) on Table A-1. the Genome of the Reovirus 3 is RNA (and not DNA as previously printed).

EU: Adopted by CPMP, April 97, issued as CPMP/ICH/295/95
MHLW: Adopted, PMSB/ELD, Notification n° 329, 22 February 2000
FDA: Published in the Federal Register, Vol. 63, No. 185, September 24, 1998, page 51074

Q5B: Quality of Biotechnological Products :
 Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products

The tripartite harmonised ICH guideline was finalised (Step 4) in November 1995. It advises on the types of information that are considered valuable in assessing the structure of the expression construct used to produce recombinant DNA derived proteins.

EU: Adopted by CPMP, December 95, issued as CPMP/ICH/139/95
MHLW: Adopted January 98, PMSB/ELD Notification No.3
FDA: Published in the Federal Register, Vol. 61, February 23, 1996, page 7006

Q5C: Quality of Biotechnological Products :
 Stability Testing of Biotechnological/Biological Products

The tripartite harmonised ICH guideline was finalised (Step 4) in November 1995. This document augments the stability guideline (Q1A above) and deals with the particular aspects of stability test procedures needed to take account of the special characteristics of products in which the active components are typically proteins and/or polypeptides.

EU: Adopted by CPMP, December 95, issued as CPMP/ICH/138/95
MHLW: Adopted January 98, PMSB/ELD Notification No.6
FDA: Published in the Federal Register, Vol. 61, July 10, 1996, page 36466

Q5D:  Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products

The tripartite harmonised ICH guideline was finalised (Step 4) in July 1997. This document provides broad guidance on appropriate standards for the derivation of human and animal cell lines and microbes used to prepare biotechnological/biological products and for the preparation and characterisation of cell banks to be used for production.

EU: Adopted by CPMP, September 97, issued as CPMP/ICH/294/95
MHLW: Adopted July 14, 2000, PMSB/ELD, Notification No. 873
FDA: Published in the Federal Register, Vol. 63, No. 182, September 21, 1998, pages 50244-49

Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process

The tripartite harmonised ICH guideline was finalised (Step 4) in November 2004. The objective of this document is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. Therefore, this guideline is intended to assist in the collection of relevant technical information which serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product. The document does not prescribe any particular analytical, nonclinical or clinical strategy. The main emphasis of the document is on quality aspects.
Q5E Final Concept Paper, February 2002

EU: Adopted by CMPM, December 1, 2004, CPMP/ICH/5721/03, date for coming into operation : June 2005
MHLW: Adopted 26 April 2005, PFSB/ELD Notification No. 0426001
FDA: Published in the Federal Register, Vol. 70, No. 125, June 30, 2005, pages 37861-37862

Q6 : Specifications for New Drug Substances and Products

Bulk drug substance and final product specifications are key parts of the core documentation for world-wide product license applications. However, there is little international guidance on how to set such specifications with a result that regulators and manufacturers often find themselves setting or agreeing to conflicting standards for the same product, as part of the registration in different regions. This leads to increased expenses and opportunities for error as well as a potential cause for interruption of product supply.

Work is therefore underway to provide harmonised guidance in this area. The Topic is divided into two parts: Chemical Substances (Q6A) and Biotechnological/Biological Substances (Q6B).

The harmonisation of about 10 compendial test chapters have been considered as critical by the ICH Steering Committee to attaining full utility of the ICH Q6A guideline. These chapters are at various stages of harmonisation among the three pharmacopeial organisations (USP, JP & EP). The three organisations conduct their harmonisation efforts through a tripartite pharmacopeial harmonisation program known as the Pharmacopoeial Discussion Group (PDG). The representatives of the PDG were participants in the ICH Q6A EWG and continue to collaborate with the Q6A EWG on completion of the harmonisation for the test chapters.

The members of the PDG are also proposing to the ICH Steering Committee mechanisms for the continued participation in the ICH process for compendial harmonisation topics.

Q6A: Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances

The tripartite harmonised ICH guideline was finalised (Step 4) in October 1999. This addresses the process of selecting tests and methods and setting specifications for the testing of drug substances and dosage forms. Account has been taken of the considerable guidance and background information which are present in existing regional documents.

Decision Trees

EU: Adopted by CPMP, November 1999, issued as CPMP/ICH/367/96
MHLW: Adopted May 1, 2001, PMSB/ELD, Notification No. 568
FDA: Published in the Federal Register, December 29, 2000, Volume 65, Number 251, Notices, Page 83041-83063

Q6B: Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

The tripartite harmonised ICH guideline was finalised (Step 4) in March 1999. This document provides guidance on justifying and setting specifications for proteins and polypeptides which are derived from recombinant or non-recombinant cell cultures. The scope of this part is initially limited to well-characterised biotechnological products, although the concepts may be applicable to other biologicals as appropriate. In view of the nature of the products, the topic of specifications include in-process controls, bulk drug, final product and stability specifications and give guidance for a harmonised approach to determining appropriate specifications based on safety, process consistency, purity, analytical methodology, product administration and clinical data considerations.

EU: Adopted by CPMP, March 99, issued as CPMP/ICH/365/96
MHLW: Adopted May 1, 2001, PMSB/ELD, Notification No. 571
FDA: Published in the Federal Register, August 18, 1999: 64FR Page 44928

Q7 : Good Manufacturing Practices for Pharmaceutical Ingredients

Early in the ICH Process it was agreed that there was adequate international agreement on the technical aspects of Good Manufacturing Practices (GMP) for Pharmaceutical Products and that further harmonisation action through ICH was not needed. Recently, however, attention has focused on the need to formalise GMP requirements for the components of pharmaceutical products - both active and inactive. In February 1998, the ICH Steering Committee agreed that GMP for Active Pharmaceutical Ingredients (APIs) should be adopted as an ICH Topic

Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

When this topic was adopted, the Steering Committee took steps to ensure that due account was taken of the work already in progress by PIC/S, FDA and other parties. In view of the unusually wide implications of this Topic, a much extended EWG has been established which includes, in addition to the six ICH parties and the Observers, experts representing IGPA (generics industry), WSMI (self medication industry) and PIC/S. With respect to the latter representatives from China, India and Australia have been invited to participate. 

EU: Adopted by CPMP, November 2000, issued as CPMP/ICH/1935/00
MHLW: Adopted November 2, 2001, PMSB Notification No. 1200
FDA: Published in the Federal Register, Vol. 66, No 186, September 25, 2001, Pages 49028 to 49029

Q8: Pharmaceutical Development

The tripartite harmonised ICH guideline was finalised (Step 4) in November 2005. 
This guideline is intended to provide guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). The guideline does not apply to contents of submissions for drug products during the clinical research stages of drug development. However the principles in this guideline are important to consider during these stages. This guideline might also be appropriate for other types of products. To determine the applicability of this guideline for a particular type of product, applicants should consult with the appropriate regulatory authorities.
Q8 Final Concept Paper, September 2003

See also Annex to Q8

EU: Transmission to CHMP and to Interested Parties in December 2004. Issued as EMEA/CHMP/167068/2004-ICH. Deadline for comments : June 2005. Final approval by CHMP: November 2005. Date for coming into operation: May 2006.
MHLW: Adopted on September 1, 2006, PFSB/ELD Notification N° 0901001
FDA: Published in the Federal Register, Vol. 71, No 98, Monday, May 22, 2006

Annex to Q8: Pharmaceutical Development

This guideline has been released for consultation under Step 2 of the ICH process on 1 November 2007.
This guideline is an annex to Q8: Pharmaceutical Development, and provides further clarification of key concepts outlined in the core guideline. In addition, this annex describes the principles of quality by design (QbD). The annex is not intended to establish new standards: however, it shows how concepts and tools (e.g., design space) outlined in the parent Q8 document could be put into practice by the applicant for all dosage forms. Where a company chooses to apply quality by design and quality risk management (Q9: Quality Risk Management), linked to an appropriate pharmaceutical quality system, then opportunities arise to enhance science- and risk-based regulatory approaches (see Q10: Pharmaceutical Quality System)

EU: Transmission to CHMP and Interested Parties in November 2007. Issued as EMEA/CHMP/ICH/518819/2007). Deadline for comments: May 2008
MHLW: Released for consultation 17 March 2008, PFSB/ELD, deadline for comments 16 May 2008
FDA: Published in the Federal Register: January 10, 2008, Volume 73, Number 7, Page 1890-1891, Deadline for comments April 9, 2008

Q9: Quality Risk Management

The tripartite harmonised ICH guideline was finalised (Step 4) in November 2005.
This guideline provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labeling materials.
Q9 Final Concept Paper, November 2003

Q9 Final Business Plan, November 2003

Access from here the Q9 Briefing Pack

EU: Published on the EMEA website, with an Explanatory Note
MHLW: Adopted on September 1, 2006, PFSB/ELD Notification n° 0901004
FDA: Published in the Federal Register, Vol. 71, No 106, pages 32105-32106, June 2, 2006

Q10: Pharmaceutical Quality System

The tripartite harmonised ICH guideline was finalised (Step 4) in June 2008
This guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.
The elements of Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognizing the differences among, and the different goals of each stage.
Q10 Final Concept Paper, September 2005

Q10 Final Business Plan, October 2005

EU: Issued as CHMP/ICH/214732/04 in July 2008. Date for coming into operation : June 2008
MHLW: To be notified
FDA: To be notified