Multidisciplinary Guidelines

  Download here the Multidisciplinary Guidelines in Word-format.

Ask the ICH Secretariat for a CD-ROM containing all the ICH guidelines. Click here to see the complete list of guidelines.

M1

Medical Terminology (see MedDRA)

The working group has provided a new Medical Dictionary for Regulatory Activities Terminology (MedDRA Terminology) that is intended for international adoption. It is designed to support the classification, retrieval, presentation and communication of medical information throughout the medical product regulatory/life cycle. Its goal is to provide a comprehensive and specific terminology to help standardize, facilitate and simplify regulatory processes.

M2

Electronic Standards for Transmission of Regulatory Information (ESTRI)  

M3

Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (See Safety Topics)

This multidisciplinary document addresses principles for the development of non-clinical strategies on the timing of toxicity studies in relation to the conduct of clinical trials. The guideline represents an important step forward on requirements for the different phases of clinical development but it is recognised that there remain some further important issues yet to be resolved.

M4

The Common Technical Document (See CTD section for complete Status of the guidelines)

The Common Technical Document provides for a harmonised structure and format for new product applications. The Common Technical Document was agreed upon in November 2000 in San Diego, USA. This Common Technical Document is divided into four separate sections. The four sections address the application organisation (M4 organise), the Quality section (M4Q), the Safety section (M4S) and the Efficacy section (M4E) of the harmonised application. The agreed upon implementation date for the Common Technical Document, in the three regions, was July 2003.

An electronic version of the Common Technical Document (eCTD) can be produced using the specifications and other information developed by the eCTD Implementation Working Group.

Annex : Granularity Document

The "Granularity Document" of the M4 Organisation defines a series of standards for the physical construction of CTD submissions. These are applicable to both the paper CTD and the eCTD. The appendix defines the granularity of the documents, their pagination, the use of section numbers, the use of tab dividers (for the paper CTD) and what to include in the Tables of Content for each module (for the paper CTD). The granularity aspects describe what constitutes a document, i.e., divided by tabs and numbered separately in the paper submission and, in an eCTD, provided as separate files. It also defines at what level in the table of contents documents/files should be placed and where multiple documents/files may be provided for a particular section.

Questions and Answers :

In order to help users deal with issues which may arise during attempts to use the CTD, the ICH has supplied a Questions & Answers section on the ICH web site to answer most, if not all, questions anyone may have. If issues arise that are not answered on the web site, additional questions can be submitted for a formal response.

M5

M5: Data Elements and Standards for Drug Dictionaries This guideline has been released for consultation under Step 2 of the ICH process on 10 May 2005.  The lack of internationally harmonized standards related to core sets of medicinal product information and medicinal product terminology is hindering the scientific evaluation and comparison of product data as well as healthcare. This applies in particular to the area of pharmacovigilance, where the exchange and management of medicinal product information in expedited and periodic adverse reaction reports at the international level is a key aspect of ensuring drug safety. This document provides guidance on the harmonized standards that are being proposed by the ICH M5 EWG to facilitate the exchange and practical use of medicinal product data by regulators and pharmaceutical industry. M5 Final Concept Paper, June 2004 M5 Final Business Plan, June 2004
Routes of Administration Controlled Vocabulary, developed by the M5 Expert Working Group, 10 May 2005, published for information.
Units and Measurements Controlled Vocabulary, developed by the M5 Expert Working Group, 10 May 2005, published for information.
M5	Consultation (Step 3) : EU : Transmission to CHMP and to interested parties, May 2005, issued as EMEA/CHMP/ICH168535/2005, deadline for comments : September 2005. MHLW : Released for consultation on 21st July 2005, PFSB/SD, deadline for comments 16th September 2005. FDA : Published in the Federal Register on Tuesday, September 6, 2005, Vol. 70, No. 171, pages 53021-53022. Deadline for comments by October 21, 2005.	Status : Step 3 May 2005

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Updated : 18/08/08