№ lp_1_2_18571
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The document outlines the specifications and guidelines for implementing the European Union Module 1 of the eCTD v4.0.
Year:
2024
Region / City:
European Union
Topic:
eCTD Implementation
Document Type:
Technical Guide
Organization / Institution:
Health Level Seven (HL7)
Author:
Not specified
Target Audience:
Regulatory bodies, developers, and industry professionals involved in eCTD implementation
Effective Period:
2024
Approval Date:
March 2024
Date of Changes:
March 2024
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The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Topic:
eCTD, registration dossier, Ministry of Health of Ukraine
Document Type:
Order
Organization / Institution:
Ministry of Health of Ukraine
Target Audience:
Regulatory authorities, applicants for medicinal product registration
Year:
2009
Region / city:
South Africa
Subject:
Registration of medicines
Document type:
Guideline
Organization / institution:
South African Health Products Regulatory Authority (SAHPRA)
Author:
Not specified
Target audience:
Applicants for registration of medicines
Period of validity:
Ongoing
Date of approval:
Not specified
Date of amendments:
May 2019
Version:
7
Date of implementation:
June 2011
Deadline for comment:
September 30, 2010
Year:
Not specified
Jurisdiction:
South Africa
Regulatory authority:
South African Health Products Regulatory Authority (SAHPRA)
Document type:
Regulatory validation checklist
Document format:
eCTD
Subject area:
Medicinal product variations
Product type:
Human medicinal products
Application type:
Variation application
Intended submitter:
Holder of certificate of registration
Submission scope:
Administrative, technical, and business validation
Regulatory modules referenced:
CTD Modules 1–5
Use context:
Initial and follow-up eCTD sequences
Approval status fields:
Included
Language:
English
Year:
2015
Region / City:
Thailand
Topic:
eCTD Specification, Regulatory Submission, Pharmaceutical Industry
Document Type:
Technical Specification
Organization / Institution:
Thai FDA
Author:
Thai FDA
Target Audience:
Pharmaceutical companies, regulatory professionals
Validity Period:
Ongoing
Approval Date:
01/12/2015
Date of Changes:
Not specified
Version:
1.2
Date:
4th of October 2024
OID:
2.16.840.1.113883.3.989.5.1.1.6.1.2
Document Change History:
2012-2024
Year:
2024
Region / City:
EU
Theme:
Electronic submission, regulatory requirements
Document Type:
Technical Guide
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Regulatory bodies, pharmaceutical industry
Effective Period:
2024 and beyond
Approval Date:
4th October 2024
Modification Date:
N/A
Year:
2001
Type of document:
Regulatory guidance
Scope:
Pharmacokinetics data reporting for nonclinical studies
Applicable region:
International (ICH)
Referenced guidelines:
M4 Organization of the Common Technical Document, M4S: The CTD — Safety and Safety Appendices
Target audience:
Pharmaceutical industry, regulatory affairs professionals
Document format:
Templates and tables for data presentation
Key topics:
Absorption, distribution, metabolism, excretion, plasma protein binding, study in pregnant or nursing animals
Year:
N/A
Region / City:
N/A
Subject:
Pharmaceutical Documentation, eCTD
Document Type:
Regulatory Guidance
Organization / Institution:
FDA
Author:
N/A
Target Audience:
Pharmaceutical Industry
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
Year:
2023
Region / City:
South Africa
Topic:
eCTD validation for new registration of medicinal products
Document Type:
Template
Organization:
SAHPRA
Author:
Not specified
Target Audience:
Applicants submitting new registration applications for medicinal products in eCTD format
Effective Period:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Note:
Year
Topic:
Clinical Research / Protocol Development
Document Type:
Protocol Template
Organization / Institution:
DMID
Author:
DMID
Target Audience:
Clinical Researchers, Investigators
Year:
2025
Region / City:
London
Topic:
Neonatal BCG vaccination program
Document Type:
Protocol
Organization / Institution:
NHSE
Author:
Alice Waters
Target Audience:
Healthcare professionals involved in neonatal care and immunization
Period of validity:
Not specified
Approval Date:
Not specified
Date of changes:
September 2025
Year:
2023
Region / City:
Australia
Theme:
Animal Welfare, Research Protocol
Document Type:
Research Guidance
Institution:
Australian National University (ANU)
Author:
ANU Veterinary Services
Target Audience:
Researchers, Animal Technicians, Veterinary Staff
Period of Validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2023
Note:
Region / City
Topic:
Sustainable Development, Building Performance
Document Type:
Form
Organization / Institution:
Evergreen
Target Audience:
Project teams, consultants, architects
Context:
A form outlining project mission, goals, design tools, team roles, and communication strategies for the Evergreen Sustainable Development Standard (ESDS) implementation.
Version:
1.2
Date:
4th of October 2024
OID:
2.16.840.1.113883.3.989.5.1.1.6.1.2
Document Change History:
2012-2024
Year:
2024
Region / City:
EU
Theme:
Electronic submission, regulatory requirements
Document Type:
Technical Guide
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Regulatory bodies, pharmaceutical industry
Effective Period:
2024 and beyond
Approval Date:
4th October 2024
Modification Date:
N/A
Year:
2025
Region / City:
United States
Subject:
Clinical Quality Incentive Program
Document Type:
Technical Specifications Manual
Organization:
Executive Office of Health and Human Services (EOHHS)
Author:
Executive Office of Health and Human Services (EOHHS)
Target Audience:
Hospitals, data vendors
Period of Validity:
2026
Approval Date:
December 22, 2025
Revision Date:
Not specified
Year:
2025
Region / City:
Australia
Theme:
Quality Management, Professional Practice
Document Type:
Manual
Organ / Institution:
Institute of Public Accountants
Author:
Institute of Public Accountants
Target Audience:
Professional Practice Certificate holders providing non-assurance services
Period of Action:
2025 and onwards
Approval Date:
January 2025
Modification Date:
Not specified
Year:
2025
Region / city:
Australia
Topic:
Quality Management
Document Type:
Manual
Organization / Institution:
Institute of Public Accountants (IPA)
Author:
Institute of Public Accountants
Target Audience:
PPC holders, Sole Practitioners
Effective Period:
January 2025 and ongoing
Approval Date:
January 2025
Amendment Date:
None specified
Year:
2023
Region / City:
Australia
Topic:
Animal Welfare, Research Protocol
Document Type:
Guidelines
Organization:
Australian National University
Author:
ANU Veterinary Services
Target Audience:
Researchers, Animal Technicians, Veterinary Staff
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
Guidelines for assessing the health and welfare of older mice in research using a standardized scoring system in line with ethical protocols.
Standard Version:
4.0
Document Title:
Evergreen Sustainable Development Standard Project Priorities Survey
Subject:
Sustainable development, affordable housing, building performance, greenhouse gas emissions, community engagement
Geographic Reference:
Washington State
Referenced Legislation:
Clean Energy Transformation Act (CETA)
Referenced Organization:
Enterprise Community Development
Referenced Tool:
Opportunity360
Document Type:
Project survey questionnaire
Intended Users:
Housing developers and project teams
Key Topics:
Organizational capacity, resident population, community stakeholders, building performance, utility benchmarking, embodied carbon, renewable energy, resilience planning
Required Attachments:
Project Dashboard PDF from Opportunity360
Year:
2019
Region / City:
Worldwide
Theme:
BIMx API, BIMx Extensions
Document Type:
Technical Documentation
Author:
Gyuri Nyitrai
Target Audience:
Developers, Construction IT Providers, FM Solution Providers
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / City:
Scotland
Topic:
Family Liaison Officers, Police Procedures
Document Type:
Guidance
Department / Organization:
Major Crime/MISCU
Author:
Not specified
Target Audience:
Police officers and staff
Effective Period:
Not specified
Approval Date:
17/10/2023
Revision Date:
Not specified
Human Rights Act 1998 Compliance:
Articles 6, 8, 9, and Protocol 1, Article 1 addressed
Summary:
This document outlines the procedures for deploying Family Liaison Officers (FLOs) in police investigations, providing guidance on supporting bereaved families while maintaining professional standards and ensuring consideration of diverse needs, including cultural and religious factors.