№ lp_1_2_36265
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Regulatory guidance describing standardized tabular presentation of nonclinical pharmacology data for CTD Module 2.6.3 in line with ICH M4S and eCTD numbering conventions.
Document type:
Regulatory guidance
Subject area:
Nonclinical pharmacology summaries
CTD module:
Module 2.6.3
Standard referenced:
ICH M4S — The CTD Safety
Submission format:
eCTD
Regulatory framework:
Common Technical Document
Issuing organizations referenced:
International Council for Harmonisation, U.S. Food and Drug Administration
Referenced guidance dates:
August 2001
Content elements:
Primary pharmacodynamics, secondary pharmacodynamics, safety pharmacology, pharmacodynamic drug interactions
Technical requirements:
INN usage, GLP compliance identification, study numbering, CTD location referencing
Source type:
Guidance with annotated sample tables
Price: 8 / 10 USD
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Year of publication:
2023
Jurisdiction:
United Kingdom
Document type:
Regulatory template
Regulation:
Benchmark Regulation (UK version of Regulation (EU) 2016/1011)
Relevant article:
Article 26(3)
Purpose:
Non-significant benchmark compliance statement
Intended users:
Benchmark administrators
Date of creation:
[dd/mm/yy]
Date of last update:
[dd/mm/yy]
Benchmarks covered:
List of non-significant benchmarks including ISINs
Document type:
Regulatory guidance
Subject:
Pharmacovigilance reporting
Regulatory framework:
ICH E2F
Scope:
Clinical trials of investigational medicinal products
Reporting obligation:
Annual safety reporting
Intended recipients:
Regulatory authorities, ethics committees, sponsors
Key entities referenced:
Medicines and Healthcare Products Regulatory Agency (MHRA)
Covered document sections:
Executive summary, safety actions, cumulative exposure, adverse event reporting
Confidentiality status:
Contains confidential and unblinded safety data
Applies to:
Non-commercial sponsors
Year:
2016
Region / city:
Not specified
Subject:
Clinical trial regulations, GCP compliance
Document type:
Checklist
Institution:
Not specified
Author:
Not specified
Target audience:
Investigators, trial staff
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Note:
Year
Subject:
Intangible Cultural Heritage (ICH)
Document Type:
Questionnaire
Target Audience:
Communities involved in ICH practices, researchers, organizations
Contextual description:
A model questionnaire for identifying elements of intangible cultural heritage when creating inventories.
Note:
Year
Contextual Description:
International ethical and scientific standards for conducting clinical trials with human subjects, outlining compliance with ICH-GCP Guidelines and additional requirements for NYU’s HRPP.
Year:
2024
Region / City:
Paris
Theme:
Disaster Risk Reduction, Intangible Cultural Heritage
Document Type:
Lesson Plan
Organization:
UNESCO
Author:
UNESCO
Target Audience:
Stakeholders involved in the inventorying, safeguarding, and mobilization of intangible cultural heritage in disaster contexts
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Modifications:
Not specified
Year:
2026
Region:
European Union / Non-EU agencies
Subject:
Pharmaceutical quality assessment
Document type:
Regulatory submission form
Organization:
European Medicines Agency
Author:
Not specified
Target audience:
Regulatory affairs professionals
Period covered:
Not specified
Date issued:
2026
Reference standard:
ICH Common Technical Document
Subject Area:
Clinical research regulation
Document Type:
Regulatory document review worksheet
Related Standards:
ICH GCP Guidelines; 45 CFR 46; 21 CFR 50; 21 CFR 312
Institution / Authority Referenced:
Division of Microbiology and Infectious Diseases (DMID)
Regulatory Authority Referenced:
U.S. Food and Drug Administration (FDA)
Ethics Oversight Reference:
Office for Human Research Protections (OHRP)
Purpose:
Guidance for completion, review, and maintenance of essential regulatory documents for clinical trials
Document Structure:
Tier-based classification of regulatory documents with section and page references
Document Tiers:
Tier 1A; Tier 1B; Tier 2; Closeout Documents
Key Forms Referenced:
Form FDA 1572; Investigator of Record Form; Financial Disclosure Form
Key Roles Referenced:
Principal Investigator; Sub-Investigator; Clinical Site Monitor
Oversight Bodies Referenced:
Institutional Review Board (IRB); OHRP
Applicable Study Types:
DMID-supported IND and IDE clinical studies
Primary Users:
Site staff conducting DMID supported studies; clinical site monitors; DMID contractors
Core Documentation Covered:
Investigator credentials, IRB approvals, informed consent documentation, laboratory certifications, regulatory compliance records
Compliance Focus:
Verification of adherence to Good Clinical Practice and applicable federal regulations
Year:
2012–2021
Region / City:
Washington State, USA
Document Type:
Membership roster
Organization:
SACH (State Advisory Council on Homelessness), ICH (Interagency Council on Homelessness)
Positions Included:
Local Government Representatives, Non-Profit Representatives, Housing Authority Representative, Philanthropic Representative, Federal Government Representative, Homeless Person Representatives, Business Representative, ICH Agency Representatives, Youth Representative
Appointments:
Various dates 2012–2017
Expirations:
Various dates 2018–2021
Contact Information:
Included for each member and agency representative
Affiliated Agencies:
Kitsap County Department of Human Services, Washington State Coalition Against Domestic Violence, Okanogan County Community Action Council, Lower Columbia Community Action Program, Kennewick Housing Authority, Campion Foundation, U.S. Department of Housing and Urban Development, Department of Commerce, DSHS divisions, Employment Security Department, Department of Veterans Affairs, Health Care Authority, Office of Superintendent of Public Instruction, State Board of Community and Technical Colleges, Department of Corrections, Governor’s Executive Policy Office
Purpose:
Lists appointed members and agency representatives with roles, contact details, and term information
Year:
2026
Region / City:
International
Topic:
Quality Risk Management in Pharmaceuticals
Document Type:
Workshop Overview
Organization / Institution:
ICH
Author:
Not specified
Intended Audience:
Pharmaceutical professionals and quality managers
Related Guidelines:
ICH Q9, ICH Q10
Content Focus:
Risk assessment, risk control, risk communication, risk review, managing subjectivity and bias, use of data and knowledge