№ lp_1_2_36267
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Regulatory guidance on the structure of eCTD submissions, including template numbering and content organization for drug product documentation.
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
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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
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
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:
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:
2017
Region / City:
European Union
Topic:
eCall Service, Emergency Communication
Document Type:
Recommendation
Organization / Institution:
European Conference of Postal and Telecommunications Administrations (ECC)
Author:
Not specified
Target Audience:
National authorities, mobile network operators, vehicle manufacturers
Validity Period:
From 22 November 2017
Approval Date:
22 November 2017
Amendment Date:
December 2020
Year:
2023
Region / City:
United States
Subject:
Pharmaceutical Regulatory Guidance
Document Type:
Guidance
Organization / Institution:
FDA
Author:
FDA
Target Audience:
Industry stakeholders, Sponsors, Applicants
Effective Period:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Note:
Contextual Description
Year:
2023
Region / City:
Global
Topic:
Biopharmaceutical studies, bioavailability, bioequivalence
Document Type:
Regulatory Guidance
Agency / Institution:
FDA, EMA
Author:
Not specified
Target Audience:
Industry professionals in pharmaceuticals
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Note:
Year
Year:
2026
Region / City:
Global
Topic:
Clinical Efficacy Studies
Document Type:
Guidance
Author:
FDA
Target Audience:
Industry professionals in pharmaceuticals
Action Period:
Ongoing
Approval Date:
N/A
Modification Date:
N/A
Description:
Regulatory guidance on the structure and numbering of templates in eCTD submissions, with a focus on the proper organization and presentation of efficacy studies in pharmaceutical documentation.
Year:
2026
Region / city:
USA, Canada
Topic:
Active substance evaluation
Document Type:
Regulatory document
Organization:
Regulatory Authority (PMRA, EPA)
Author:
Applicant
Target Audience:
Regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2017
Region / City:
European Union
Theme:
eCall, Emergency Communication, Vehicle Safety, Numbering Resources
Document Type:
Recommendation
Institution:
European Conference of Postal and Telecommunications Administrations (ECC)
Author:
European Conference of Postal and Telecommunications Administrations
Target Audience:
National authorities, car manufacturers, mobile operators, PSAPs
Period of Validity:
Ongoing
Approval Date:
22 November 2017
Modification Date:
None
Year:
2020
Region / City:
Web meeting
Subject:
Minutes of the 21st WG NaN Meeting
Type of document:
Meeting minutes
Author:
Andrew Burns
Target audience:
Delegates representing CEPT administrations, ETSI, NTT, ECO
Period of validity:
15-17 December 2020
Date of approval:
15 December 2020
Date of amendments:
N/A
Year:
2018
Region / city:
The Hague, The Netherlands
Subject:
Meeting Report – PT FNI, Copenhagen
Source:
Chairman / Francesco Bernabei
Source e-mail:
[email protected]
Date of the document:
01 February 2018
Note:
Action items
Target audience:
PT FNI members
Action period:
2018
Context:
Report of the 36th PT FNI meeting, including discussions on the development of numbering strategies, work progress on number assignment, and preparations for upcoming conferences.
Year:
2025
Region / City:
International
Topic:
Document numbering system
Document Type:
Guideline
Organization / Institution:
ICCAT Secretariat
Author:
ICCAT Secretariat
Target Audience:
Delegations of CPCs
Period of validity:
2025
Approval Date:
N/A
Amendment Date:
N/A
Year:
2014
Region / City:
United States
Theme:
Fast Track Designation, Drug Development
Document Type:
Guidance
Organ / Institution:
FDA (Food and Drug Administration)
Author:
FDA
Target Audience:
Drug Sponsors, Pharmaceutical Industry
Period of Validity:
N/A
Approval Date:
N/A
Amendment Date:
N/A