Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories.  It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).
Zip file with all Multidisciplinary Guidelines in Word format

  • MedDRA Terminology M1

    Code Document Title Previously coded
    • MedDRAMedical Dictionary for Regulatory Activities
      MedDRA page
      MedDRA PtC page
      Description:

      The development of a Medical Dictionary for Regulatory Activities was approved by the ICH Steering Committee in 1997 and the terminology launched in 1999. Due to the development of this topic over the years, all information about MedDRA and the Points to Consider documents developed for every MedDRA version are available on the MedDRA page under the Work Products.

  • Electronic Standards M2

    Code Document Title Previously coded
    • ESTRIElectronic Standards for the Transfer of Regulatory Information
      Presentation on ICH work with SDOs
      ESTRI page
      Description:

      The M2 Expert Working Group (EWG) was established by the ICH Steering Committee in 1994 with the objective of facilitating international electronic communication by evaluating and recommending, open and non-proprietary - to the extent possible - Electronic Standards for the Transfer of Regulatory Information (ESTRI) that will meet the requirements of the pharmaceutical companies and regulatory authorities.

      Since its establishment the M2 EWG has been involved in a number of activities including: recommendation for use by ICH of various open international standards (M2 Recommendations); ICH development of specifications for electronic messages for the E2B(R2) ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports, as well as the M4 Common Technical Document (CTD); and the provision of technical input to the ICH E2B(R3) and M5 EWGs in their activities to progress their respective standards through the Standards Development Organisation (SDO) process.

      In November 2010, the ICH Steering Committee modified the mandate of the M2 EWG. Important changes included agreement that work related to the Electronic Common Technical Document (eCTD) be undertaken by a newly established M8 EWG, and that the M2 EWG would no longer be directly involved in the development of technical solutions in relation to topics such as E2B(R3) and M5, but would instead provide the framework for the efficient and effective development of the solutions by groups dedicated to these topics. Under its new mandate, the M2 EWG continues to be responsible for the evaluation and recommendation of standards, and also has responsibility for SDO relationship management.

  • Nonclinical Safety Studies M3

    Code Document Title Previously coded
    • M3(R2)Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

      Finalised Guideline:
      June 2009

      M3(R2)
      Concept Paper
      Presentation on M3(R2)
      Description:

      The recommendations of this revised guidance further harmonise the nonclinical safety studies to support the various stages of clinical development among the regions of European Union (EU), Japan, and the United States. The present guidance represents the consensus that exists regarding the type and duration of nonclinical safety studies and their timing to support the conduct of human clinical trials and marketing authorisation for pharmaceuticals.

      Implementation:

      Step 5

      EU:

      Approved by CHMP June 2009, issued as CPMP/ICH/286/95. Coming into operation in December 2009

      MHLW:

      Adopted on 19 February 2010, PFSB/ELD notification No. 0219-4

      FDA:

      Published in the Federal Register, Vol. 75, No 13, Docket No. FDA/2008/D/0470, p. 3471, 21 January 2010

    • M3(R2) Q&As R2Questions & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

      Finalised Q&As:
      March 2012

      M3(R2) Questions and Answers (R2)
      Concept Paper
      Description:

      While the M3(R2) is still in its early phases of the implementation, the complexity of the guidance, its broader scope, and numerous changes in recommendations from the M3(R1) guidance have generated questions that impact its successful implementation. To clarify the key issues of these document, the Steering Committee has endorsed the establishement of an M3(R2) Implementation Working Group (IWG), which is currently working on the development of Q&As.

      The document with the first set of Q&As addressing Limit Dose for Toxicity Studies, Metabolites and Reversibility of Toxicity was finalised under Step 4 in June 2011.

      In December 2011, a second set of Q&As addressing Combination Drug Toxicity Testing was developed and approved under Step 4 by the Steering Committee for integration in the Q&A document (M3(R2) Q&As (R1)).

      In March 2012, an additional question on Limit Dose for Toxicity Studies and 4 additional sections addressing Safety Pharmacology, Exploratory Clinical Trials, Reproductive Toxicity and Juvenile Animal Studies were approved under Step 4 by the Steering Committee for integration in the Q&A document (M3(R2) Q&As (R2)).

      Implementation:

      Step 5

      EU:

      Transmission to CHMP and release for information, May 2012, issued as EMA/CHMP/ICH/507008/2011

      MHLW:

      Adopted 16 August 2012, PFSB/ELD Administrative Notice

      FDA:

      Posted on FDA website on 25 February 2013

  • Common Technical Document M4

    Code Document Title Previously coded
    • CTDThe Common Technical Document
      CTD page
      Description:

      The Common Technical Document was agreed upon by the Steering Committee in November 2000. Due to the development of this topic over the years, all information about the CTD are available on the CTD page under the Work Products.

  • Data Elements and Standards for Drug Dictionaries M5

    Code Document Title Previously coded
    • M5Data Elements and Standards for Drug Dictionaries
      Presentation on ICH work with SDOs
      Description:

      The lack of internationally harmonised standards related to core sets of medicinal product information and medicinal product terminology is hindering the scientific evaluation and comparison of product data. 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 are key aspects of ensuring drug safety.

      In 2004, the ICH Steering Committee approved the development of the ICH M5 Guideline with the aim of providing guidance on the harmonised standards being proposed by the ICH M5 EWG to facilitate the exchange and practical use of medicinal product data by regulators and pharmaceutical industry. In May 2005, the ICH M5 Guideline was released for consultation at Step 2 of the ICH process, along with controlled vocabularies lists for Routes of Administration and Units of Measurement.

      In 2006, the ICH Steering Committee took a key decision that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs) to enable wider interoperability across regulatory and healthcare communities. This Guideline was subsequently submitted to ISO, the International Organization for Standardization, for development under this process.

      The M5 Step 2 Guideline was updated based upon feedback received during consultation in 2005, as well as additional considerations following its submission to ISO for development as an International Standard. Key parts of this updated guideline will be incorporated into the ICH Implementation Guide for Identification of Medicinal Products Message Specification which is currently undergoing development as an ISO standard.

  • Gene Therapy M6

    Code Document Title Previously coded
    • M6Virus and Gene Therapy Vector Shedding and Transmission
      Concept Paper
      Appendix 1
      Appendix 2
      Business Plan
      Description:

      This new topic was endorsed by the ICH Steering Committee in September 2009.

      In September 2009, following the finalisation by the ICH Gene Therapy Discussion Group (GTDG) of the ICH Consideration document “General Principles to Address Virus and Vector Shedding”, the ICH Steering Committee endorsed the development of an ICH Guideline on this topic with the aim of providing more extensive information to improve harmonisation amongst the ICH regions. This new topic was subsequently assigned the code “M6”. In April 2011, this topic was ceased following SC discussion that concluded due to the current state of science and related resource allocation would not allow this to be supported as a topic for harmonisation.

  • Genotoxic Impurities M7

    Code Document Title Previously coded
    • M7Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

      Draft Document:
      February 2013

      M7
      Concept Paper
      Business Plan
      Presentation on M7
      Contribute to the M7 Document
      Description:

      The M7 draft Guideline has been released for consultation under Step 2 of the ICH process in February 2013.

      This new Guideline is proposed to offer guidance on analysis of structure activity relationships (SAR) for genotoxicity. Furthermore, it is intended to resolve questions such as whether impurities with similar alerts that potentially have similar mechanism of action should not be combined in calculating a Threshold of Toxicological (TCC) and whether the TTC may differ based on differences in the approved duration of use.

      Consultation:

      Step 2

      EU:

      Transmission to CHMP in February 2013, issued as EMA/CHMP/ICH/83812/2013. Deadline for comments: 23 April 2013

      MHLW:

      Released for consultation, 6 March 2013. Deadline for comments: 30 April 2013

      FDA:

      Published in the Federal Register 15 April 2013, Vol. 78, No. 72, p. 22269-70. Deadline for comments: 14 June 2013

  • Electronic Common Technical Document (eCTD) M8

    Code Document Title Previously coded
    • Electronic Common Technical Document (eCTD)
      Concept Paper
      Presentation on M8
      Step 2 for testing page on ESTRI website
      Description:

      In November 2010, the ICH Steering Committee endorsed the establishment of an Expert Working Group (EWG) / Implementation Working Group (IWG) for the eCTD and assigned the topic code "M8". Work in relation to the eCTD had previously been undertaken by the M2 EWG.

      Under the M8 remit is the support of the progression of the eCTD through the Standards Development Organisation (SDO) process to develop the eCTD as an International Standard. This is in accordance with the 2008 Steering Committee decision that the next major version of the eCTD be developed in collaboration with SDOs, with development first as a Health Level Seven (HL7) standard, and then as an International Organization for Standardization (ISO) standard.

      In October 2012, the Draft eCTD Implementation Guide (v0.1) was released under Step 2 for Testing to give an opportunity to stakeholders to conduct testing to confirm its technical feasibility.
      The ICH eCTD Draft Implementation Guide v1.0 and the Draft ICH Code List are made available for public awareness until March 1, 2013.
      Further information and the Step 2 for Testing document package can be found on the eCTD Step 2 for Testing page of the ESTRI site.

      Also under the M8 remit is work to maintain the current ICH specifications for the eCTD and Study Tagging File. This work is a continuation of that undertaken by the eCTD IWG sub-group which was previously a part of the M2 EWG.

      CTD Quality Implementation Working Group

      Concept Paper
      ESTRI page
      Description:

      In October 2007, the ICH Steering Committee endorsed the establishment of a CTD-Quality Implementation Working Group to assist the then M2 eCTD IWG sub-group with addressing Questions/Change Requests received in relation to the organisation of the Quality section of the eCTD (Modules 2 & 3). This group continues to work to address the quality issues which have been identified for integration as Questions & Answers (Q&As) into the Change Request/Q&A document available on the ESTRI page.