ICH
| Title | Link |
|---|---|
| ICH - Guidance for Industry E 10 Choice of Control Group and Related Issues in Clinical Trials - May 2001 - (37 pages) | http://www.fda.gov/cder/guidance/4155fnl.pdf |
| ICH - Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH M2 EWG Electronic Common Technical Document Specification - 2002 - (160 pages) | http://www.fda.gov/cder/m2/eCTD%20Step%202/eCTD%20Specification%20v2-0-1.pd |
| ICH M2 EWG Electronic Common Technical Document Specification- Technical Requirements for registration of pharmaceuticals for human use - February 12, 2002 - (160 pages) | http://www.fda.gov/cder/guidance/5017dft.pdf |
| ICH Q1E - Draft Consensus Guideline Evaluation of Stability Data - 7 February 2002 | http://www.fda.gov/cder/guidance/4983dft.pdf |
| ICH Q1F Draft Consensus Guideline - Stability Data Package for Registration in Climatic Zones III and IV - February 7, 2002 - (5 pages) | http://www.fda.gov/cder/guidance/4984dft.pdf |
| ICH - E1 - The extent of population exposure to assess clinical safety for long-term treatment of non-life-threatening conditions - (5 pages) | http://www.ich.org/pdfICH/e1.pdf |
| ICH - E2C - Clinical safety data management: periodic safety update reports for marketed drugs - 1996 - (22 pages) | http://www.ich.org/pdfICH/e2c.pdf |
| ICH - E3 - Structure and Content of Clinical Study Reports - 1995 - (50 pages) | http://www.ich.org/pdfICH/e3.pdf |
| ICH - E4 - Dose-Responde Information to Support Drug Registration - 1994 - (14 pages) | http://www.ich.org/pdfICH/e4.pdf |
| ICH - Studies in Support of Special Populations: Geriatrics - 1993 - (5 pages) | http://www.ich.org/pdfICH/e7.pdf |
| ICH - E8 - General Considerations for Clinical trials - 1997 - (15 pages) | http://www.ich.org/pdfICH/e8.pdf |
| ICH - E9 - Statistical principles for Clinical trials - 1998 - (40 pages) | http://www.ich.org/pdfICH/e9.pdf |
| ICH - E10 - Choice of control group and related issues in clinical trials - 2000 - (35 pages) | http://www.ich.org/pdfICH/e10step4.pdf |
| ICH - E11 - Clinical investigation of medicinal products in the pediatric population - 2000 - (16 pages) | http://www.ich.org/pdfICH/e11step4.pdf |
| ICH - E12 - draft - Principles for Clinical Evaluation of new Antihypertensive Drugs - 2000 - (12 pages) | http://www.ich.org/pdfICH/e12.pdf |
| ICH - E6 -Guideline for Good Clinical Practice - 1996 - (57 pages) | http://www.ich.org/pdfICH/e6.pdf |
| Stability Testing of New Drug Substances and Products (Step 5) | http://www.ifpma.org/pdfifpma/q1arstep4.pdf |
| Guideline on Photostability Testing (Step 5) | http://www.ifpma.org/pdfifpma/q1b.pdf |
| Guideline on Stability Testing for New Dosage Forms Step 5 | http://www.ifpma.org/pdfifpma/q1c.pdf |
| Guideline on Impurities in New Drug Substances (Revised Guideline) (Step 3) | http://www.ifpma.org/word/Q3Arstep2.doc |
| Impurities in New Drug Products (Revised Guideline) (Step 3) | http://www.ifpma.org/word/Q3Brstep2.doc |
| Q6B Guideline on Biotechnological Substances (Step 5) | http://www.ifpma.org/pdfifpma/Q6bstep4.pdf |
| Q7A Guideline on Good Manufacturing Practices for Active Pharmaceutical Ingredients Step 5 | http://www.ifpma.org/pdfifpma/Q7Astep4.PDF |
| International Conference on Harmonisation - ICH - home page | http://www.ifpma.org/ich1.html |
| ICH - Harmonisation process | http://www.ifpma.org/ich4.html |
| ICH - list of guidelines | http://www.ifpma.org/ich5.html |
| FDA- International Conference on Harmonization - Public Meeting - Transcripts - 10:30 a.m.- Thursday, January 17, 2002 | http://www.fda.gov/cder/audiences/iact/meeting_transcript_011702.htm |
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Last updated: July 8, 2002