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

  • M1 MedDRA Terminology

    Code Document Title Previously coded
    • 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.

  • M2 Electronic Standards

    Code Document Title Previously coded
    • 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.

  • M3 Nonclinical Safety Studies

    Code Document Title Previously coded
    • Finalised Guideline:
      June 2009

      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

    • 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

  • M4 Common Technical Document

    Code Document Title Previously coded
    • 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.

  • M5 Data Elements and Standards for Drug Dictionaries

    Code Document Title Previously coded
    • Description:

      In November 2003, the ICH Steering Committee endorsed a Concept Paper for Topic M5 and subsequently formed an M5 Expert Working Group (EWG) to develop ICH requirements for the standardisation of medicinal product identifiers and related terminology. In particular, a need was identified to harmonise product information that would facilitate the electronic exchange of Individual Case Safety Reports (ICSRs) within and across ICH regions using the ICH E2B format in post-marketing pharmacovigilance.

      In May 2005, an M5 consensus draft Guideline containing ICH business requirements for medicinal product identifiers, along with lists of controlled vocabularies for Routes of Administration and Units of Measurements, was published for public consultation at Step 2 of the ICH process. To support the electronic exchange of the M5 data elements proposed by the M5 EWG, technical messaging specifications were needed. Electronic messaging development for utilization by the ICH Parties had been the domain of the ICH M2 EWG, but in June 2006 the ICH Steering Committee took a key decision to develop electronic specifications in collaboration with Standards Development Organisations (SDOs). This would enable wider interoperability across regulatory and healthcare communities.

      The M5 draft Guideline, updated to reflect feedback from the public consultation, was subsequently submitted to the International Organization for Standardization (ISO) for development of electronic messaging specifications in February 2007. Work was conducted as a joint initiative with several other SDOs, including Health Level 7 (HL7), and various global stakeholders, including experts with experience on the ICH M5 EWG, were active participants. Abbreviated regional testing was performed by the ICH Parties and five International Standards for Identification of Medicinal Products (IDMP) were finalized and published by ISO in November 2012. These five ISO standards not only meet the original ICH needs for electronic exchange of ICSRs in post-marketing pharmacovigilance, but also support broader functionality.

      Having successfully finalised the International Standards for IDMP, the ICH Steering Committee acknowledged the considerable achievements of the M5 EWG and agreed to the sunset of the M5 EWG in June 2013. Subsequently, the ICH Steering Committee formed a new E2B Implementation Working Group (IWG) to facilitate implementation of the new E2B(R3) standard for electronic ICSR exchange. The remit of the E2B IWG includes the use of the five ISO IDMP standards (ISO11238:2012, ISO11239:2012, ISO11240:2012, ISO11615:2012, and ISO11616:2012) only for the purpose of electronic ICSR exchange. Therefore, IDMP maintenance and publication requirements are outside the scope of the E2B IWG.

  • M6 Gene Therapy

    Code Document Title Previously coded
    • 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.

  • M7 Genotoxic Impurities

    Code Document Title Previously coded
  • M8 Electronic Common Technical Document (eCTD)

    Code Document Title Previously coded
    • 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

      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.