ICH Guidelines http://www.ich.org/ The ICH Topics are divided into four major categories and ICH Topic Codes are assigned according to these categories. en ICH Guidelines http://www.ich.org/fileadmin/templates/img/icon_rss.png http://www.ich.org/ 30 34 The ICH Topics are divided into four major categories and ICH Topic Codes are assigned according to these categories. TYPO3 - get.content.right http://blogs.law.harvard.edu/tech/rss Wed, 28 Nov 2018 16:37:00 +0100 Efficacy Guidelines http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/efficacy-guidelines.html The work carried out by ICH under the Efficacy heading is concerned with the design, conduct,...
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Efficacy Guidelines Mon, 16 Aug 2010 00:00:00 +0200
Statistical Principles for Clinical Trials http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/statistical-principles-for-clinical-trials.html E9 Statistical Principles for Clinical Trials Thu, 01 Jan 1970 02:41:20 +0100 Addendum: Statistical Principles for Clinical Trials http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/addendum-statistical-principles-for-clinical-trials-copy-1.html E9 Statistical Principles for Clinical Trials Thu, 01 Jan 1970 02:41:20 +0100 Genomic Sampling and Management of Genomic Data http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/genomic-sampling-and-management-of-genomic-data.html E18 Genomic Sampling Tue, 19 Aug 2014 18:06:00 +0200 Safety Guidelines http://www.ich.org/products/guidelines/safety/safety-single/article/safety-guidelines.html ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like...
Stakeholders are invited to report Safety Guideline issues at safety@ich.org.]]>
Safety Guidelines Tue, 17 Aug 2010 00:00:00 +0200
Nonclinical Safety Testing in Support of Development of Paediatric Medicines http://www.ich.org/products/guidelines/safety/safety-single/article/nonclinical-safety-testing-in-support-of-development-of-paediatric-medicines.html S11 Nonclinical Paediatric Safety Wed, 10 Dec 2014 09:01:00 +0100 Multidisciplinary Guidelines http://www.ich.org/ Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and...
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Multidisciplinary Guidelines Sun, 15 Aug 2010 00:00:00 +0200
General principles for planning and design of Multi-Regional Clinical Trials http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/general-principle-on-planningdesigning-multi-regional-clinical-trials.html E17 Multi-Regional Clinical Trials Tue, 19 Aug 2014 17:42:00 +0200 Quality Guidelines http://www.ich.org/products/guidelines/quality/quality-single/article/quality-guidelines.html Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of...
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Quality Guidelines Wed, 18 Aug 2010 00:00:00 +0200
Bioanalytical Method Validation http://www.ich.org/ M10 Bioanalytical Method Validation Wed, 19 Oct 2016 14:34:00 +0200 General principles for planning and design of Multi-Regional Clinical Trials http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/general-principles-for-planning-and-design-of-multi-regional-clinical-trials-copy-1.html E17 Multi-Regional Clinical Trials Thu, 22 Mar 2018 13:38:00 +0100 Clinical electronic Structured Harmonised Protocol (CeSHarP) http://www.ich.org/ M11 Clinical electronic Structured Harmonised Protocol (CeSHarP) Thu, 22 Nov 2018 16:59:00 +0100 Biopharmaceutics Classification System-based Biowaivers http://www.ich.org/ M9 Biopharmaceutics Classification System-based Biowaivers Wed, 19 Oct 2016 14:17:00 +0200 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/the-extent-of-population-exposure-to-assess-clinical-safety-for-drugs-intended-for-long-term-treatme.html E1 Clinical Safety for Drugs used in Long-Term Treatment Thu, 01 Jan 1970 01:38:24 +0100 Good Clinical Practice (GCP) http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendum-good-clinical-practice.html E6 Good Clinical Practice Fri, 15 Aug 2014 17:46:00 +0200 Clinical Safety Data Management: Definitions and Standards for Expedited Reporting http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-safety-data-management-definitions-and-standards-for-expedited-reporting.html E2A - E2F Pharmacovigilance Sat, 01 Oct 1994 00:00:00 +0100 Medical Dictionary for Regulatory Activities http://www.ich.org/ M1 MedDRA Terminology Thu, 09 Sep 2010 22:00:00 +0200 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management http://www.ich.org/products/guidelines/quality/quality-single/article/technical-and-regulatory-considerations-for-pharmaceutical-product-lifecycle-management.html Q12 Lifecycle Management Fri, 10 Oct 2014 12:16:00 +0200 Continuous Manufacturing of Drug Substances and Drug Products http://www.ich.org/products/guidelines/quality/quality-single/article/technical-and-regulatory-considerations-for-pharmaceutical-product-lifecycle-management-copy-1.html Q13 Continuous Manufacturing of Drug Substances and Drug Products Thu, 22 Nov 2018 17:06:00 +0100 Stability Testing of New Drug Substances and Products http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-new-drug-substances-and-products.html Q1A - Q1F Stability Thu, 19 Aug 2010 10:51:00 +0200 Rodent Carcinogenicity Studies for Human Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/rodent-carcinogenicity-studies-for-human-pharmaceuticals.html S1A - S1C Carcinogenicity Studies Mon, 14 May 2012 12:06:00 +0200 Stability Testing : Photostability Testing of New Drug Substances and Products http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-photostability-testing-of-new-drug-substances-and-products.html Q1A - Q1F Stability Thu, 19 Aug 2010 11:00:00 +0200 Stability Testing for New Dosage Forms http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-for-new-dosage-forms.html Q1A - Q1F Stability Thu, 19 Aug 2010 11:10:00 +0200 Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products http://www.ich.org/products/guidelines/quality/quality-single/article/bracketing-and-matrixing-designs-for-stability-testing-of-new-drug-substances-and-products.html Q1A - Q1F Stability Thu, 19 Aug 2010 11:15:00 +0200 Evaluation of Stability Data http://www.ich.org/products/guidelines/quality/quality-single/article/evaluation-of-stability-data.html Q1A - Q1F Stability Thu, 19 Aug 2010 11:21:00 +0200 Stability Data Package for Registration Applications in Climatic Zones III and IV http://www.ich.org/products/guidelines/quality/quality-single/article/stability-data-package-for-registration-applications-in-climatic-zones-iii-and-iv.html Q1A - Q1F Stability Thu, 19 Aug 2010 11:26:00 +0200 Analytical Procedure Development and Revision of Q2(R1) Analytical Validation http://www.ich.org/products/guidelines/quality/quality-single/article/validation-of-analytical-procedures-text-and-methodology.html Q2 Analytical Validation Thu, 22 Nov 2018 17:11:00 +0100 Analytical Procedure Development http://www.ich.org/products/guidelines/quality/quality-single/article/analytical-procedure-development-and-revision-of-q2r1-analytical-validation-copy-1-1.html Q14 Analytical Procedure Development Wed, 28 Nov 2018 16:09:00 +0100 Validation of Analytical Procedures: Text and Methodology http://www.ich.org/products/guidelines/quality/quality-single/article/analytical-procedure-development-and-revision-of-q2r1-analytical-validation-copy-1.html Q2 Analytical Validation Thu, 19 Aug 2010 18:38:00 +0200 Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-safety-data-management-data-elements-for-transmission-of-individual-case-safety-reports.html E2A - E2F Pharmacovigilance Mon, 12 Sep 2011 01:00:00 +0200 Electronic Standards for the Transfer of Regulatory Information http://www.ich.org/ M2 Electronic Standards Thu, 05 Aug 2010 04:35:00 +0200 Need for Carcinogenicity Studies of Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/need-for-carcinogenicity-studies-of-pharmaceuticals.html S1A - S1C Carcinogenicity Studies Fri, 30 Jul 2010 00:00:00 +0200 Implementation: Electronic Transmission of Individual Case Safety Reports http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/implementation-electronic-transmission-of-individual-case-safety-reports.html E2A - E2F Pharmacovigilance Fri, 19 Jul 2013 18:07:00 +0200 Periodic Benefit-Risk Evaluation Report http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/periodic-benefit-risk-evaluation-report.html E2A - E2F Pharmacovigilance Mon, 20 Feb 2012 01:00:00 +0100 Questions & Answers: Periodic Benefit-Risk Evaluation Report http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/questions-answers-periodic-benefit-risk-evaluation-report.html E2A - E2F Pharmacovigilance Fri, 26 Apr 2013 10:07:00 +0200 Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals http://www.ich.org/ M3 Nonclinical Safety Studies Sun, 08 Aug 2010 00:00:00 +0200 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/the-clinical-evaluation-of-qtqtc-interval-prolongation-and-proarrhythmic-potential-for-non-antiarrh.html E14 Clinical Evaluation of QT Thu, 01 Jan 1970 01:25:36 +0100 Questions & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals http://www.ich.org/ M3 Nonclinical Safety Studies Fri, 23 Mar 2012 01:00:00 +0100 Testing for Carcinogenicity of Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/testing-for-carcinogenicity-of-pharmaceuticals.html S1A - S1C Carcinogenicity Studies Sat, 31 Jul 2010 00:00:00 +0200 The Common Technical Document http://www.ich.org/ M4 Common Technical Document Fri, 09 Jul 2010 09:31:15 +0200 Impurities in New Drug Substances http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-in-new-drug-substances.html Q3A - Q3D Impurities Thu, 19 Aug 2010 11:38:00 +0200 Dose Selection for Carcinogenicity Studies of Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/dose-selection-for-carcinogenicity-studies-of-pharmaceuticals.html S1A - S1C Carcinogenicity Studies Thu, 12 Aug 2010 00:00:00 +0200 Data Elements and Standards for Drug Dictionaries http://www.ich.org/ M5 Data Elements and Standards for Drug Dictionaries Sun, 04 Jul 2010 22:20:37 +0200 Principles for Clinical Evaluation of New Antihypertensive Drugs http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/principles-for-clinical-evaluation-of-new-antihypertensive-drugs.html E12 Clinical Evaluation by Therapeutic Category Thu, 01 Jan 1970 01:21:20 +0100 Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use http://www.ich.org/products/guidelines/safety/safety-single/article/guidance-on-genotoxicity-testing-and-data-interpretation-for-pharmaceuticals-intended-for-human-use.html S2 Genotoxicity Studies Mon, 28 Nov 2011 01:00:00 +0100 Electronic Common Technical Document (eCTD) http://www.ich.org/ M8 Electronic Common Technical Document (eCTD) Fri, 10 Dec 2010 06:57:00 +0100 Impurities in New Drug Products http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-in-new-drug-products.html Q3A - Q3D Impurities Thu, 19 Aug 2010 11:50:00 +0200 Impurities: Guideline for Residual Solvents http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-guideline-for-residual-solvents.html Ongoing Q3A - Q3D Impurities Wed, 06 Dec 2017 15:06:00 +0100 Virus and Gene Therapy Vector Shedding and Transmission http://www.ich.org/ M6 Gene Therapy Fri, 03 Dec 2010 05:22:00 +0100 Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies http://www.ich.org/products/guidelines/safety/safety-single/article/note-for-guidance-on-toxicokinetics-the-assessment-of-systemic-exposure-in-toxicity-studies.html S3A - S3B Toxicokinetics and Pharmacokinetics Sun, 01 Aug 2010 00:00:00 +0200 Impurities: Guideline for Residual Solvents http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-guideline-for-residual-solvents-copy-1.html Q3A - Q3D Impurities Fri, 23 Mar 2018 19:45:00 +0100 Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling http://www.ich.org/products/guidelines/safety/safety-single/article/questions-and-answers-note-for-guidance-on-toxicokinetics-the-assessment-of-systemic-exposure-fo.html S3A - S3B Toxicokinetics and Pharmacokinetics Sun, 01 Aug 2010 00:00:00 +0200 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk http://www.ich.org/ M7 Mutagenic impurities Thu, 07 Feb 2013 00:00:00 +0100 Guideline for Elemental Impurities http://www.ich.org/products/guidelines/quality/quality-single/article/guideline-for-elemental-impurities.html Q3A - Q3D Impurities Wed, 12 Jan 2011 08:58:00 +0100 Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies http://www.ich.org/products/guidelines/safety/safety-single/article/pharmacokinetics-guidance-for-repeated-dose-tissue-distribution-studies.html S3A - S3B Toxicokinetics and Pharmacokinetics Mon, 02 Aug 2010 00:00:00 +0200 Revision of Q3D Cadmium Inhalation PDE http://www.ich.org/products/guidelines/quality/quality-single/article/guideline-for-elemental-impurities-copy-1.html Q3A - Q3D Impurities Sun, 03 Jun 2018 10:19:00 +0200 Revision of Q3D for cutaneous and transdermal products http://www.ich.org/products/guidelines/quality/quality-single/article/revision-of-q3d-for-cutaneous-and-transdermal-products.html Q3A - Q3D Impurities Sun, 03 Jun 2018 09:34:00 +0200 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk http://www.ich.org/ M7 Mutagenic impurities Mon, 26 Mar 2018 09:57:00 +0200 Implementation of Guideline for Elemental Impurities http://www.ich.org/products/guidelines/quality/quality-single/article/implementation-of-guideline-for-elemental-impurities-copy-1.html Q3A - Q3D Impurities Tue, 02 Dec 2014 12:10:00 +0100 Pharmacopoeias http://www.ich.org/products/guidelines/quality/quality-single/article/pharmacopoeias.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 12:29:00 +0200 Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing) http://www.ich.org/products/guidelines/safety/safety-single/article/duration-of-chronic-toxicity-testing-in-animals-rodent-and-non-rodent-toxicity-testing.html S4 Toxicity Testing Thu, 12 Aug 2010 00:00:00 +0200 Pharmacopoeial Harmonisation http://www.ich.org/products/guidelines/quality/quality-single/article/pharmacopoeial-harmonisation.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 12:49:00 +0200 Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility http://www.ich.org/products/guidelines/safety/safety-single/article/detection-of-toxicity-to-reproduction-for-medicinal-products-toxicity-to-male-fertility.html S5 Reproductive Toxicology Tue, 03 Aug 2010 00:00:00 +0200 Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/revision-of-s5-guideline-on-detection-of-toxicity-to-reproduction-for-medicinal-products-toxicity.html S5 Reproductive Toxicology Tue, 03 Aug 2010 00:00:00 +0200 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions http://www.ich.org/products/guidelines/quality/quality-single/article/evaluation-and-recommendation-of-pharmacopoeial-texts-for-use-in-the-ich-regions.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 12:51:00 +0200 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/preclinical-safety-evaluation-of-biotechnology-derived-pharmaceuticals.html S6 Biotechnological Products Tue, 05 Jul 2011 01:00:00 +0200 Residue on Ignition/Sulphated Ash General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/residue-on-ignitionsulphated-ash-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 13:00:00 +0200 Test for Extractable Volume of Parenteral Preparations General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/test-for-extractable-volume-of-parenteral-preparations-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 13:06:00 +0200 Test for Particulate Contamination: Sub-Visible Particles General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/test-for-particulate-contamination-sub-visible-particles-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 13:10:00 +0200 Safety Pharmacology Studies for Human Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/safety-pharmacology-studies-for-human-pharmaceuticals.html S7A - S7B Pharmacology Studies Wed, 04 Aug 2010 00:00:00 +0200 The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/the-non-clinical-evaluation-of-the-potential-for-delayed-ventricular-repolarization-qt-interval-pro.html S7A - S7B Pharmacology Studies Thu, 05 Aug 2010 00:00:00 +0200 Questions & Answers: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential http://www.ich.org/products/guidelines/safety/safety-single/article/questions-answers-clinical-and-non-clinical-evaluation-of-qtqtc-interval-prolongation-and-proarr.html S7A - S7B Pharmacology Studies Wed, 28 Nov 2018 16:37:00 +0100 Immunotoxicity Studies for Human Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/immunotoxicity-studies-for-human-pharmaceuticals.html S8 Immunotoxicology Studies Fri, 06 Aug 2010 00:00:00 +0200 Nonclinical Evaluation for Anticancer Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/nonclinical-evaluation-for-anticancer-pharmaceuticals.html S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Sun, 15 Aug 2010 00:00:00 +0200 Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/questions-and-answers-nonclinical-evaluation-for-anticancer-pharmaceuticals.html S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Sun, 15 Aug 2010 00:00:00 +0200 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/microbiological-examination-of-non-sterile-products-microbial-enumeration-tests-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 13:14:00 +0200 Photosafety Evaluation of Pharmaceuticals http://www.ich.org/products/guidelines/safety/safety-single/article/photosafety-evaluation-of-pharmaceuticals.html S10 Photosafety Evaluation Sat, 07 Aug 2010 00:00:00 +0200 Ethnic Factors in the Acceptability of Foreign Clinical Data http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/ethnic-factors-in-the-acceptability-of-foreign-clinical-data.html E5 Ethnic Factors Thu, 01 Jan 1970 02:25:20 +0100 Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/questions-answers-ethnic-factors-in-the-acceptability-of-foreign-clinical-data.html E5 Ethnic Factors Thu, 01 Jan 1970 01:34:08 +0100 Microbiological Examination of Non-Sterile Products: Tests for Specified Micro-Organisms General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/microbiological-examination-of-non-sterile-products-tests-for-specified-micro-organisms-general-cha.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 13:56:00 +0200 Dose-Response Information to Support Drug Registration http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/dose-response-information-to-support-drug-registration.html E4 Dose-Response Studies Thu, 01 Jan 1970 01:12:48 +0100 Microbiological Examination of Non-Sterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/microbiological-examination-of-non-sterile-products-acceptance-criteria-for-pharmaceutical-preparat.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 14:05:00 +0200 Studies in Support of Special Populations: Geriatrics http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/studies-in-support-of-special-populations-geriatrics.html E7 Clinical Trials in Geriatric Population Thu, 01 Jan 1970 02:33:52 +0100 Questions & Answers: Studies in Support of Special Populations : Geriatrics http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/questions-answers-studies-in-support-of-special-populations-geriatrics.html E7 Clinical Trials in Geriatric Population Thu, 01 Jan 1970 02:39:12 +0100 General Considerations for Clinical Trials http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/general-considerations-for-clinical-trials.html E8 General Considerations for Clinical Trials Thu, 01 Jan 1970 02:40:16 +0100 Optimisation of Safety Data Collection http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/addendum-statistical-principles-for-clinical-trials.html E19 Safety Data Collection Wed, 26 Jul 2017 15:55:00 +0200 Choice of Control Group and Related Issues in Clinical Trials http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/choice-of-control-group-and-related-issues-in-clinical-trials.html E10 Choice of Control Group in Clinical Trials Thu, 01 Jan 1970 02:41:52 +0100 Disintegration Test General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/disintegration-test-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 14:09:00 +0200 Uniformity of Dosage Units General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/uniformity-of-dosage-units-general-chapter.html Q4 - Q4B Pharmacopoeias Mon, 13 Jan 2014 00:00:00 +0100 Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/addendum-clinical-investigation-of-medicinal-products-in-the-pediatric-population.html E11 - E11A Clinical Trials in Pediatric Population Tue, 19 Aug 2014 18:03:00 +0200 Dissolution Test General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/dissolution-test-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 14:32:00 +0200 Sterility Test General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/sterility-test-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 14:39:00 +0200 Tablet Friability General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/tablet-friability-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 14:43:00 +0200 Paediatric Extrapolation http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-investigation-of-medicinal-products-in-the-pediatric-population-copy-1.html E11 - E11A Clinical Trials in Pediatric Population Fri, 01 Dec 2017 17:16:00 +0100 Polyacrylamide Gel Electrophoresis General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/polyacrylamide-gel-electrophoresis-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 14:47:00 +0200 Capillary Electrophoresis General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/capillary-electrophoresis-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 14:51:00 +0200 Analytical Sieving General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/analytical-sieving-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 19 Aug 2010 14:54:00 +0200 Bulk Density and Tapped Density of Powders General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/bulk-density-and-tapped-density-of-powders-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 07 Jun 2012 00:00:00 +0200 Bacterial Endotoxins Test General Chapter http://www.ich.org/products/guidelines/quality/quality-single/article/bacterial-endotoxins-test-general-chapter.html Q4 - Q4B Pharmacopoeias Thu, 18 Oct 2012 00:00:00 +0200 Frequently Asked Questions http://www.ich.org/products/guidelines/quality/quality-single/article/frequently-asked-questions.html Q4 - Q4B Pharmacopoeias Thu, 26 Apr 2012 00:00:00 +0200 Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin http://www.ich.org/products/guidelines/quality/quality-single/article/viral-safety-evaluation-of-biotechnology-products-derived-from-cell-lines-of-human-or-animal-origin.html Q5A - Q5E Quality of Biotechnological Products Thu, 19 Aug 2010 15:02:00 +0200 Cross-cutting Guidelines http://www.ich.org/products/guidelines/safety/safety-single/article/cross-cutting-guidelines.html Cross-cutting Topics Cross-cutting Topics Cross-cutting Topics Wed, 06 Jul 2011 11:11:00 +0200 Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products http://www.ich.org/products/guidelines/quality/quality-single/article/analysis-of-the-expression-construct-in-cells-used-for-production-of-r-dna-derived-protein-products.html Q5A - Q5E Quality of Biotechnological Products Thu, 19 Aug 2010 15:03:15 +0200 Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/post-approval-safety-data-management-definitions-and-standards-for-expedited-reporting.html E2A - E2F Pharmacovigilance Thu, 01 Jan 1970 02:04:00 +0100 Stability Testing of Biotechnological/Biological Products http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-biotechnologicalbiological-products.html Q5A - Q5E Quality of Biotechnological Products Thu, 19 Aug 2010 15:11:00 +0200 Pharmacovigilance Planning http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/pharmacovigilance-planning.html E2A - E2F Pharmacovigilance Thu, 01 Jan 1970 02:08:16 +0100 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/definitions-for-genomic-biomarkers-pharmacogenomics-pharmacogenetics-genomic-data-and-sample-cod.html E15 Definitions in Pharmacogenetics / Pharmacogenomics Thu, 01 Jan 1970 01:29:52 +0100 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/biomarkers-related-to-drug-or-biotechnology-product-development-context-structure-and-format-of-qu.html E16 Qualification of Genomic Biomarkers Sun, 01 Aug 2010 00:00:00 +0200 Development Safety Update Report http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/development-safety-update-report.html E2A - E2F Pharmacovigilance Sat, 01 Jan 2011 00:00:00 +0100 Structure and Content of Clinical Study Reports http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/structure-and-content-of-clinical-study-reports.html E3 Clinical Study Reports Thu, 01 Jan 1970 01:08:32 +0100 Questions & Answers: Structure and Content of Clinical Study Reports http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/questions-answers-structure-and-content-of-clinical-study-reports.html E3 Clinical Study Reports Thu, 21 Jun 2012 00:00:00 +0200 Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/questions-answers-the-clinical-evaluation-of-qtqtc-interval-prolongation-and-proarrhythmic-poten.html E14 Clinical Evaluation of QT Thu, 17 Dec 2015 17:19:00 +0100 Questions & Answers: Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/discussion-group-on-clinical-and-non-clinical-evaluation-of-qtqtc-interval-prolongation.html E14 Clinical Evaluation of QT Thu, 21 Apr 2016 16:55:00 +0200 Revision on General Considerations for Clinical Trials http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/paediatric-extrapolation-copy-1.html E8 General Considerations for Clinical Trials Mon, 26 Mar 2018 15:18:00 +0200 Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products http://www.ich.org/products/guidelines/quality/quality-single/article/derivation-and-characterisation-of-cell-substrates-used-for-production-of-biotechnologicalbiologica.html Q5A - Q5E Quality of Biotechnological Products Thu, 19 Aug 2010 15:15:00 +0200 Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process http://www.ich.org/products/guidelines/quality/quality-single/article/comparability-of-biotechnologicalbiological-products-subject-to-changes-in-their-manufacturing-proc.html Q5A - Q5E Quality of Biotechnological Products Thu, 19 Aug 2010 15:23:00 +0200 Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-new-drug-substances-and-new-drug-produc.html Q6A- Q6B Specifications Thu, 19 Aug 2010 15:29:00 +0200 Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-biotechnologicalbiological-products.html Q6A- Q6B Specifications Thu, 19 Aug 2010 15:37:00 +0200 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients http://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.html Q7 Good Manufacturing Practice Thu, 19 Aug 2010 15:45:00 +0200 Quality Risk Management http://www.ich.org/products/guidelines/quality/quality-single/article/quality-risk-management.html Q9 Quality Risk Management Thu, 19 Aug 2010 16:02:00 +0200 Pharmaceutical Development http://www.ich.org/products/guidelines/quality/quality-single/article/pharmaceutical-development.html Q8 Pharmaceutical Development Thu, 19 Aug 2010 15:51:00 +0200 Pharmaceutical Quality System http://www.ich.org/products/guidelines/quality/quality-single/article/pharmaceutical-quality-system.html Q10 Pharmaceutical Quality System Thu, 19 Aug 2010 16:14:00 +0200 Q8/Q9/Q10 - Implementation http://www.ich.org/products/guidelines/quality/quality-single/article/q8q9q10-implementation.html Q10 Pharmaceutical Quality System Q9 Quality Risk Management Q8 Pharmaceutical Development Thu, 07 Jul 2011 01:00:00 +0200 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) http://www.ich.org/products/guidelines/quality/quality-single/article/development-and-manufacture-of-drug-substances-chemical-entities-and-biotechnologicalbiological-en.html Q11 Development and Manufacture of Drug Substances Thu, 10 May 2012 01:00:00 +0200 Questions & Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances http://www.ich.org/products/guidelines/quality/quality-single/article/questions-answers-selection-and-justification-of-starting-materials-for-the-manufacture-of-drug-s.html Q11 Development and Manufacture of Drug Substances Wed, 10 Dec 2014 08:37:00 +0100 Questions and Answers: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients http://www.ich.org/products/guidelines/quality/quality-single/article/questions-and-answers-good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.html Q7 Good Manufacturing Practice Wed, 31 Oct 2012 00:00:00 +0100