ICH Topics and Guidelines
The ICH Topics are divided into four major categories and ICH Topic Codes are assigned according to these categories. The Guidelines deriving from the Topics are frequently referred to using the ICH Codes. Summary charts giving the Status of Harmonisation of the ICH Topics and Guidelines is provided via the following links and copies of guidelines which have reached Step 2/3 or Step 4/5 can be downloaded as Adobe Acrobat (PDF) files.
|Q =||"Quality" Topics, i.e., those relating to chemical and pharmaceutical Quality Assurance.
Examples: Q1 Stability Testing, Q3 Impurity Testing
|S =||"Safety" Topics, i.e., those relating to in vitro and in vivo pre-clinical studies. Examples: S1 Carcinogenicity Testing, S2 Genotoxicity Testing|
|E =||"Efficacy" Topics, i.e., those relating to clinical studies in human subject. Examples: E4 Dose Response Studies, Carcinogenicity Testing, E6 Good Clinical Practices. (Note Clinical Safety Data Management is also classified as an "Efficacy" topic - E2)|
|M =||Multidisciplinary Topics, i.e., cross-cutting Topics which do not fit uniquely into one of the above categories.|
To download the documents presented as Adobe Acrobat (PDF) files, your browser will have to be configured either to read pdf files directly or save them to disk for viewing with Acrobat Reader.
Problems have occurred when downloading some of the PDFs from some of the PharmWeb mirror sites. The PDF files are now being served up from the main PharmWeb server.
For information on the Steps in the development of a guideline, see the ICH Process
"Click" on the image to go to the ESTRI site (Electronic Standards for the Transfer of Regulatory Information)
In addition to listing M2 functionality and the current recommendations, this site offers information on M2 background, objectives, approach, and foreseen impact in various regions.
Printed Copies of the Guidelines
Printed copies of the ICH guidelines that have reached Step 2 (regulatory consultation) and Step 4 (finalized) may be obtained from the ICH Secretariat and copies are also available on Diskette (MS Word 6).
A charge is made to cover the cost of printing, postage and packaging, but single sets can be provided free of charge to governmental and academic institutions and organizations in developing countries.
Contact: ICH Secretariat at firstname.lastname@example.org giving a fax number, to receive details for ordering. Information can also be provided on the availablitiy of the Guidelines and Proceedings on CD ROM.
A short video (12 minutes) describing the structure and function of ICH, which was shown at ICH 4, can be purchased from the ICH Secretariat. Copies can be provided free of charge for educational purposes to non-profit organisations. Please state language (English, Japanese) and format (PAL, SECAM, NTCS) for information on price.
We hope that you will find this site helpful. Date of current revision: February 1998.
Please send comments regarding technical aspects of these web page or the retrieval of documents to Dr. Michael Williams Address enquiries on the progress of Topics to Margaret Cone, IFPMA
Copyright© 1998, 1997 International Federation of Pharmaceutical Manufacturers Associations