№ lp_1_2_50678
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Character count: 28841
File size: 115 KB
The document is a template used for verifying the completeness of information submitted for the new registration of medicinal products in eCTD format to SAHPRA.
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
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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:
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
Note:
Year
Topic:
Clinical Research / Protocol Development
Document Type:
Protocol Template
Organization / Institution:
DMID
Author:
DMID
Target Audience:
Clinical Researchers, Investigators
Year:
2004
Region / City:
International
Topic:
Process Validation, Medical Device Manufacturing
Document Type:
Guideline
Organization / Institution:
Philips
Author:
Philips Quality Engineering
Target Audience:
External suppliers, manufacturers of medical devices
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2023
Region / City:
Khyber Pakhtunkhwa
Theme:
Digital Governance, Workflow & Document Management System, Third-Party Validation
Document Type:
Terms of Reference
Organization / Institution:
Khyber Pakhtunkhwa Revenue Mobilization & Public Resource Management Program (KPRMP)
Author:
KPRMP
Target Audience:
Third-Party Firms, IT Consultants, and Government Agencies
Period of Validity:
06 months
Approval Date:
Not specified
Modification Date:
Not specified
Contextual Description:
Terms of Reference for engaging a third-party firm to validate the deliverables submitted by Netsol Technologies in the development of a Workflow & Document Management System for the Khyber Pakhtunkhwa government.
Note:
and the site visit team chair eight (8) weeks prior to the site visit)(4.2024)
Year:
2024
Region / City:
N/A
Theme:
Accreditation
Document Type:
Schedule Template
Organization / Institution:
ARC-PA
Author:
N/A
Target Audience:
Program administrators, Site visit team
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2024
Region / City:
United Kingdom
Topic:
Woodland Carbon Code, Project Validation
Document Type:
Project Design Document (PDD)
Organization / Institution:
UK Land Carbon Registry
Author:
Vicky West
Target Audience:
Project or Group Managers seeking Woodland Carbon Code validation
Period of Action:
Ongoing until project completion
Approval Date:
April 2024
Date of Amendments:
April 2024
Year:
2025
Region / City:
Singapore
Topic:
Target Validation, Drug Discovery
Document Type:
Call for Proposals
Organization:
Singapore Therapeutics Development Review (STDR)
Author:
N/A
Target Audience:
Researchers, Principal Investigators, Institutions
Period of Action:
2025
Approval Date:
N/A
Date of Last Changes:
N/A
Note:
Year
Year:
2017
Region / State:
California
Topic:
Information Technology, Independent Verification and Validation
Document Type:
Statement of Work
Organization / Agency:
California Department of Technology
Author:
Not specified
Period of Performance:
Effective Date through optional twelve-month extension
Contract Type:
Federally Funded Contract
Deliverables:
Deliverable Expectation Documents (DEDs), status reports, invoices
Staff Requirements:
Minimum five years IV&V experience, technical knowledge of IEEE Std. 1012, bachelor’s degree or equivalent
Work Location:
Onsite at State-designated locations, some tasks offsite if preapproved
Security Requirements:
Security and Data Protection compliance
Budget/Payment:
Specified in Exhibit B-1, Cost Worksheet
Year:
2016-2017
Region / City:
Escambia River
Topic:
EFDC Model Calibration and Validation
Document Type:
Data Report
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers, Modelers
Period of Validity:
2016-2017
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2026
Region / City:
United States
Topic:
Data Validation, Eligibility Documentation
Document Type:
Directive
Agency / Institution:
State Government
Author:
Unknown
Target Audience:
State agencies, program administrators, and relevant stakeholders
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified