Home \ MULTIDISCIPLINARY GUIDELINES
Multidisciplinary Guidelines
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).
M1 MedDRA
Terminology
M2 Electronic
Standards
M3 Nonclinical Safety
Studies
M4 Common Technical
Document
M5 Data Elements and Standards for Drug
Dictionaries
M6 Gene
Therapy
M7 Mutagenic
Impurities
M8 Electronic Common Technical Document
(eCTD)
M8 eCTD v3.2.2 Electronic Common Technical Document (eCTD) v3.2.2
The Implementation Guide and related documents for the ICH M8 electronic Common
Technical Document (eCTD) v3.2.2 can be found on the ESTRI page. Related Links
ESTRI page for eCTD
Date of Step 4: 1 July 2008 V3.2.2
Status: Step 5
Implementation status:
ANMAT, Argentina - Not yet implemented;
ANVISA, Brazil - Not applicable;
COFEPRIS, Mexico - Not yet implemented;
EC, Europe - Implemented; Date: 1 January 2010; Reference: Annex 2 to the HMA
eSubmission Roadmap
EDA, Egypt - Not yet implemented;
FDA, United States - Implemented; Date: 16 July 2008; Reference: FDA-1992-S-0039 Memo
34
HSA, Singapore - In the process of implementation;
Health Canada, Canada - Implemented; Date: 1 January 2018; Reference: File #: 17-104609-
715
JFDA, Jordan - Implemented; Date: 18 October 2018;
MFDS, Republic of Korea - Implemented; Date: 30 June 2016; Reference: Regulation on
Pharmaceuticals Approval, Notification and Review [MFDS, Republic of Korea Notification]
MHLW/PMDA, Japan - Implemented; Date: 7 July 2009; Reference: PSEHB/PELD
Notification No. 0707-3
MHRA, UK - Implemented; Date: 1 January 2010;
NMPA, China - Implemented; Date: 29 December 2021; Reference: NMPA, China
Announcement No.119 (2021)
SFDA, Saudi Arabia - Implemented;
Swissmedic, Switzerland - Implemented; Date: 1 January 2010;
TFDA, Chinese Taipei - Implemented; Date: 1 January 2022; Reference: 1. Public
Announcement for CTD. Began from November, 2012/11/01, the submission of dossiers in
CTD format was mandatory for NMEs. 2. Public Announcement for applications via e-
submission 3. Checking list for API Application 4. Letter for strengthen the promotion of
drug registration and online application platform 5. Letter for promote the Drug
Registration and Online Application Platform (ExPress), the implementation schedule of
the plan is as described in the explanatory section 6. Validation Guideline and Specification
for Electronic Common Technical Document 7. Guideline for Electronic Common Technical
Documents 8. Letter forelectronic common technical document, eCTD Platform, officially
starting to operate from January 1, 2022
TITCK, Türkiye - Not yet implemented;
M8 eCTD v4.0 Electronic Common Technical Document (eCTD) v4.0
M8 EWG/IWG Electronic Common Technical Document (eCTD)
M9 Biopharmaceutics Classification System-based
Biowaivers
M10 Bioanalytical Method Validation and Study Sample
Analysis
M11 Clinical electronic Structured Harmonised Protocol
(CeSHarP)
M12 Drug Interaction
Studies
M13 Bioequivalence for Immediate-Release Solid Oral Dosage
Forms
M14 Use of real-world data for safety assessment of
medicines
M15 General Principles for Model-Informed Drug
Development