http://www.ich.org/ The ICH Topics are divided into four major categories and ICH Topic Codes are assigned according to these categories. en 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 Mon, 14 May 2012 11:06:00 +0100 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,... Zip file with all Efficacy Guidelines in Word format]]> Efficacy Guidelines Sun, 15 Aug 2010 23:00:00 +0100 http://www.ich.org/ Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and... Zip file with all Multidisciplinary Guidelines in Word format]]> Multidisciplinary Guidelines Sat, 14 Aug 2010 23:00:00 +0100 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 Clinical Safety E1 - E2F Thu, 01 Jan 1970 01:38:24 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-safety-data-management-definitions-and-standards-for-expedited-reporting.html Clinical Safety E1 - E2F Sat, 01 Oct 1994 00:00:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/maintenance-of-the-clinical-safety-data-management-including-data-elements-for-transmission-ofbrin.html Clinical Safety E1 - E2F Thu, 01 Jan 1970 01:55:28 +0100 http://www.ich.org/ MedDRA Terminology M1 Thu, 09 Sep 2010 21:00:00 +0100 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... Zip with all ICH Quality Guidelines in word format]]> Quality Guidelines Tue, 17 Aug 2010 23:00:00 +0100 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... Zip file with all ICH Safety Guidelines in Word format]]> Safety Guidelines Mon, 16 Aug 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-new-drug-substances-and-products.html Stability Q1A - Q1F Thu, 19 Aug 2010 09:51:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/new-topic-rodent-carcinogenicity-studies-for-human-pharmaceuticals.html Carcinogenicity Studies S1A - S1C Mon, 14 May 2012 11:06:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-photostability-testing-of-new-drug-substances-and-products.html Stability Q1A - Q1F Thu, 19 Aug 2010 10:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-for-new-dosage-forms.html Stability Q1A - Q1F Thu, 19 Aug 2010 10:10:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/bracketing-and-matrixing-designs-for-stability-testing-of-new-drug-substances-and-products.html Stability Q1A - Q1F Thu, 19 Aug 2010 10:15:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/evaluation-of-stability-data.html Stability Q1A - Q1F Thu, 19 Aug 2010 10:21:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/stability-data-package-for-registration-applications-in-climatic-zones-iii-and-iv.html Stability Q1A - Q1F Thu, 19 Aug 2010 10:26:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/validation-of-analytical-procedures-text-and-methodology.html Analytical Validation Q2 Thu, 19 Aug 2010 10:32:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/e2br3-clinical-safety-data-management-data-elements-for-transmission-of-individual-case-safety-re.html Clinical Safety E1 - E2F Mon, 12 Sep 2011 00:00:00 +0100 http://www.ich.org/ Electronic Standards M2 Thu, 05 Aug 2010 03:35:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/need-for-carcinogenicity-studies-of-pharmaceuticals.html Carcinogenicity Studies S1A - S1C Thu, 29 Jul 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-safety-data-management-periodic-safety-update-reports-for-marketed-drugs.html Clinical Safety E1 - E2F Fri, 01 Nov 1996 00:00:00 +0000 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/periodic-benefit-risk-evaluation-report.html Clinical Safety E1 - E2F Mon, 20 Feb 2012 00:00:00 +0000 http://www.ich.org/ Nonclinical Safety Studies M3 Sat, 07 Aug 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/the-clinical-evaluation-of-qtqtc-interval-prolongation-and-proarrhythmic-potential-for-non-antiarrh.html Clinical Evaluation E14 Thu, 01 Jan 1970 01:25:36 +0100 http://www.ich.org/ Nonclinical Safety Studies M3 Fri, 23 Mar 2012 00:00:00 +0000 http://www.ich.org/products/guidelines/safety/safety-single/article/testing-for-carcinogenicity-of-pharmaceuticals.html Carcinogenicity Studies S1A - S1C Fri, 30 Jul 2010 23:00:00 +0100 http://www.ich.org/ Common Technical Document M4 Fri, 09 Jul 2010 08:31:15 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/good-clinical-practice.html Good Clinical Practice E6 Thu, 01 Jan 1970 01:17:04 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-in-new-drug-substances.html Impurities Q3A - Q3D Thu, 19 Aug 2010 10:38:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/dose-selection-for-carcinogenicity-studies-of-pharmaceuticals.html Carcinogenicity Studies S1A - S1C Wed, 11 Aug 2010 23:00:00 +0100 http://www.ich.org/ Data Elements and Standards for Drug Dictionaries M5 Sun, 04 Jul 2010 21:20:37 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/principles-for-clinical-evaluation-of-new-antihypertensive-drugs.html Clinical Evaluation by Therapeutic Category E12 Thu, 01 Jan 1970 01:21:20 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/guidance-on-genotoxicity-testing-and-data-interpretation-for-pharmaceuticals-intended-for-human-use.html Genotoxicity Studies S2 Mon, 28 Nov 2011 00:00:00 +0000 http://www.ich.org/ Electronic Common Technical Document (eCTD) M8 Fri, 10 Dec 2010 05:57:00 +0000 http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-in-new-drug-products.html Impurities Q3A - Q3D Thu, 19 Aug 2010 10:50:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-guideline-for-residual-solvents.html Impurities Q3A - Q3D Wed, 16 Feb 2011 23:00:00 +0000 http://www.ich.org/ Gene Therapy M6 Fri, 03 Dec 2010 04:22:00 +0000 http://www.ich.org/products/guidelines/safety/safety-single/article/note-for-guidance-on-toxicokinetics-the-assessment-of-systemic-exposure-in-toxicity-studies.html Toxicokinetics and Pharmacokinetics S3A - S3B Sat, 31 Jul 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/impurities-guideline-for-metal-impurities.html Impurities Q3A - Q3D Wed, 12 Jan 2011 07:58:00 +0000 http://www.ich.org/ Genotoxic Impurities M7 Fri, 03 Dec 2010 04:32:00 +0000 http://www.ich.org/products/guidelines/safety/safety-single/article/pharmacokinetics-guidance-for-repeated-dose-tissue-distribution-studies.html Toxicokinetics and Pharmacokinetics S3A - S3B Sun, 01 Aug 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/pharmacopoeias.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 11:29:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/duration-of-chronic-toxicity-testing-in-animals-rodent-and-non-rodent-toxicity-testing.html Toxicity Testing S4 Wed, 11 Aug 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/pharmacopoeial-harmonisation.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 11:49:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/detection-of-toxicity-to-reproduction-for-medicinal-products-toxicity-to-male-fertility.html Reproductive Toxicology S5 Mon, 02 Aug 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/evaluation-and-recommendation-of-pharmacopoeial-texts-for-use-in-the-ich-regions.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 11:51:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/preclinical-safety-evaluation-of-biotechnology-derived-pharmaceuticals.html Biotechnological Products S6 Tue, 05 Jul 2011 00:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/residue-on-ignitionsulphated-ash-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 12:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/test-for-extractable-volume-of-parenteral-preparations-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 12:06:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/test-for-particulate-contamination-sub-visible-particles-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 12:10:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/safety-pharmacology-studies-for-human-pharmaceuticals.html Pharmacology Studies S7A - S7B Tue, 03 Aug 2010 23:00:00 +0100 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 Pharmacology Studies S7A - S7B Wed, 04 Aug 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/immunotoxicity-studies-for-human-pharmaceuticals.html Immunotoxicology Studies S8 Thu, 05 Aug 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/nonclinical-evaluation-for-anticancer-pharmaceuticals.html Nonclinical Evaluation for Anticancer Pharmaceuticals S9 Sat, 14 Aug 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/microbiological-examination-of-non-sterile-products-microbial-enumeration-tests-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 12:14:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/photosafety-evaluation-of-pharmaceuticals.html Photosafety Evaluation S10 Fri, 06 Aug 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/ethnic-factors-in-the-acceptability-of-foreign-clinical-data.html Ethnic Factors E5 Thu, 01 Jan 1970 02:25:20 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/questions-answers-ethnic-factors-in-the-acceptability-of-foreign-clinical-data.html Ethnic Factors E5 Thu, 01 Jan 1970 01:34:08 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/microbiological-examination-of-non-sterile-products-tests-for-specified-micro-organisms-general-cha.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 12:56:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/dose-response-information-to-support-drug-registration.html Dose-Response Studies E4 Thu, 01 Jan 1970 01:12:48 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/microbiological-examination-of-non-sterile-products-acceptance-criteria-for-pharmaceutical-preparat.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:05:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/studies-in-support-of-special-populations-geriatrics.html Clinical Trials E7 - E11 Thu, 01 Jan 1970 02:33:52 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/questions-answers-studies-in-support-of-special-populations-geriatrics.html Clinical Trials E7 - E11 Thu, 01 Jan 1970 02:39:12 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/general-considerations-for-clinical-trials.html Clinical Trials E7 - E11 Thu, 01 Jan 1970 02:40:16 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/statistical-principles-for-clinical-trials.html Clinical Trials E7 - E11 Thu, 01 Jan 1970 02:41:20 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/choice-of-control-group-and-related-issues-in-clinical-trials.html Clinical Trials E7 - E11 Thu, 01 Jan 1970 02:41:52 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-investigation-of-medicinal-products-in-the-pediatric-population.html Clinical Trials E7 - E11 Thu, 01 Jan 1970 02:42:08 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/disintegration-test-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:09:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/uniformity-of-dosage-units-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:13:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/dissolution-test-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:32:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/sterility-test-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:39:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/tablet-friability-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:43:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/polyacrylamide-gel-electrophoresis-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:47:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/capillary-electrophoresis-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:51:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/analytical-sieving-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:54:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/bulk-density-and-tapped-density-of-powders-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:56:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/bacterial-endotoxins-test-general-chapter.html Pharmacopoeias Q4 - Q4B Thu, 19 Aug 2010 13:59:00 +0100 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 Quality of Biotechnological Products Q5A - Q5E Thu, 19 Aug 2010 14:02:00 +0100 http://www.ich.org/products/guidelines/safety/safety-single/article/joint-efficacysafety-guidelines.html Cross-cutting Topics Cross-cutting Topics Cross-cutting Topics Wed, 06 Jul 2011 10:11:00 +0100 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 Quality of Biotechnological Products Q5A - Q5E Thu, 19 Aug 2010 14:03:15 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/post-approval-safety-data-management-definitions-and-standards-for-expedited-reporting.html Clinical Safety E1 - E2F Thu, 01 Jan 1970 02:04:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-biotechnologicalbiological-products.html Quality of Biotechnological Products Q5A - Q5E Thu, 19 Aug 2010 14:11:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/pharmacovigilance-planning.html Clinical Safety E1 - E2F Thu, 01 Jan 1970 02:08:16 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/definitions-for-genomic-biomarkers-pharmacogenomics-pharmacogenetics-genomic-data-and-sample-cod.html Pharmacogenomics E15 - E16 Thu, 01 Jan 1970 01:29:52 +0100 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 Pharmacogenomics E15 - E16 Sat, 31 Jul 2010 23:00:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/development-safety-update-report.html Clinical Safety E1 - E2F Fri, 31 Dec 2010 23:00:00 +0000 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/structure-and-content-of-clinical-study-reports.html Clinical Study Reports E3 Thu, 01 Jan 1970 01:08:32 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/questions-answers-structure-and-content-of-clinical-study-reports.html Clinical Study Reports E3 Thu, 14 Jul 2011 10:34:00 +0100 http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/questions-answers-the-clinical-evaluation-of-qtqtc-interval-prolongation-and-proarrhythmic-poten.html Clinical Evaluation E14 Thu, 03 May 2012 00:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/derivation-and-characterisation-of-cell-substrates-used-for-production-of-biotechnologicalbiologica.html Quality of Biotechnological Products Q5A - Q5E Thu, 19 Aug 2010 14:15:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/comparability-of-biotechnologicalbiological-products-subject-to-changes-in-their-manufacturing-proc.html Quality of Biotechnological Products Q5A - Q5E Thu, 19 Aug 2010 14:23:00 +0100 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 Specifications Q6A- Q6B Thu, 19 Aug 2010 14:29:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/specifications-test-procedures-and-acceptance-criteria-for-biotechnologicalbiological-products.html Specifications Q6A- Q6B Thu, 19 Aug 2010 14:37:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.html Good Manufacturing Practice Q7 Thu, 19 Aug 2010 14:45:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/quality-risk-management.html Quality Risk Management Q9 Thu, 19 Aug 2010 15:02:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/pharmaceutical-development.html Pharmaceutical Development Q8 Thu, 19 Aug 2010 14:51:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/pharmaceutical-quality-system.html Pharmaceutical Quality System Q10 Thu, 19 Aug 2010 15:14:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/q8q9q10-questions-answers.html Pharmaceutical Quality System Q10 Quality Risk Management Q9 Pharmaceutical Development Q8 Thu, 07 Jul 2011 00:00:00 +0100 http://www.ich.org/products/guidelines/quality/quality-single/article/development-and-manufacture-of-drug-substances.html Development and Manufacture of Drug Substances Q11 Thu, 10 May 2012 00:00:00 +0100