№ lp_1_21834
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File size: 259 KB
This document provides guidelines for submitting applications for the registration of medicines to SAHPRA, detailing the administrative information required for Module 1 of the Common Technical Document (CTD).
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
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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:
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
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:
2023
Region / City:
Zambia
Topic:
Electronic waste management
Document Type:
Environmental impact report
Author:
ZAMSTATS
Target Audience:
Environmental specialists, project managers, policymakers
Period of validity:
Ongoing throughout project lifecycle
Approval Date:
March 2023
Date of amendments:
Not specified
Note:
Contextual description
Year:
2009
Region / City:
East Africa
Topic:
Regional integration, East African Community
Institution:
Aalborg University
Author:
Klaas B. J. Overlade
Target Audience:
Researchers, policymakers, academics
Period of Validity:
N/A
Date of Approval:
01-04-2009
Date of Changes:
N/A
Note:
Year
Organization / Institution:
Kennesaw State University
Target Audience:
Students of Kennesaw State University and Georgia Highlands College Marietta
Year:
2023
Region / City:
Pelindaba, Brits, South Africa
Theme:
Nuclear Energy, Medical Radioisotopes, Procurement
Document Type:
Invitation to Bid
Organization:
South African Nuclear Energy Corporation SOC Ltd (Necsa)
Author:
Not specified
Target Audience:
Bidders, Suppliers
Validity Period:
90 Days
Approval Date:
Not specified
Amendment Date:
24 November 2023
Year:
2021
Region / City:
West and Central Africa
Topic:
Electricity, Governance, Institutional Strengthening, Africa
Document Type:
Report
Organization:
European Union, African Union Commission
Author:
Dr. Dimitris Papastefanakis, Dr. William Gboney, Dr. George Kyriakarakos, Mr. Jian Bani
Target Audience:
Policy makers, energy sector professionals
Period of Validity:
2021-2040
Approval Date:
August 31, 2021
Date of Revisions:
N/A
Year:
2023
Region / City:
Entebbe, Uganda
Subject:
African Carnivores Conservation, CITES, CMS
Document Type:
Questionnaire
Institution:
CITES, CMS
Author:
CITES and CMS Secretariats
Target Audience:
Range States of the African Carnivores Initiative
Period of Validity:
2023
Approval Date:
September 2021
Date of Changes:
N/A
Note:
Contextual Description
Year:
1866
Region / City:
United States
Subject:
Civil Rights, Legislation, African American History
Document Type:
Legislative Act
Author:
United States Congress
Target Audience:
Citizens, Legal Professionals, Historians
Period of Validity:
1866 and onward
Date of Approval:
1866
Date of Amendments:
None
Year:
2024
Region / City:
Addis Ababa, Ethiopia
Subject:
Implementation of the African Continental Free Trade Area (AfCFTA)
Document Type:
Report
Institution:
African Union
Author:
Issoufou Mahamadou, Former President of Niger and AfCFTA Champion
Target Audience:
Heads of State and Government of the African Union
Period of Effect:
Ongoing
Date of Approval:
February 2024
Date of Amendments:
None
Year:
2021
Region / City:
Africa
Theme:
Spectrum Allocation, Telecommunications
Document Type:
Planning Document
Organization / Institution:
African Telecommunications Union (ATU)
Author:
African Telecommunications Union (ATU)
Target Audience:
African National Regulators, Telecommunications Policy Makers
Period of Validity:
Ongoing, updated after each World Radiocommunications Conference (WRC)
Approval Date:
August 2021
Date of Revision:
After each WRC
Language:
English
Year:
2021
Type of document:
Request for Expression of Interest
Reference number:
CS/STATS/SCBV/2021/04
Issuing organization:
COMESA Secretariat
Program:
African Information Highway (AIH)
Position title:
Team Leader and Senior Data Scientist
Assignment type:
Individual consultancy
Region:
Africa
Maximum contract budget:
USD 150,000
Submission language:
English
Submission deadline:
18 August 2021
Contract commencement:
Within two weeks of contract signature
Evaluation method:
Technical evaluation and financial compliance
Minimum technical score:
70%
Contact persons:
Ted Peter Luka; Silver Mwesigwa
Date of issue:
28 July 2021
Year:
2025
Region / City:
Pelindaba, Brits Magisterial District, Madibeng Municipality, North West, South Africa
Theme:
HVAC system design and installation for WSRF
Document Type:
Tender Invitation
Organ / Institution:
South African Nuclear Energy Corporation (Necsa)
Author:
Not specified
Target Audience:
Qualified HVAC contractors
Period of Validity:
90 Working Days (commencing from Bid Closing Date)
Approval Date:
Not specified
Amendment Date:
Not specified