№ lp_1_2_27296
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This document provides guidelines for the registration of pharmaceutical products, detailing the required quality information across different stages of development and regulatory submission, facilitating the harmonisation of technical requirements for human medicines.
Year:
2025
Region / city:
Global
Subject:
Pharmaceutical Registration
Document Type:
Guideline
Author:
International Council for Harmonisation (ICH)
Target audience:
Regulatory authorities, pharmaceutical companies
Period of validity:
Not specified
Approval date:
14 May 2025
Date of changes:
Not specified
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Year:
2025
Region / city:
Global
Topic:
Pharmaceuticals, Quality Guidelines
Document Type:
Guideline
Organization / Institution:
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Author:
ICH Assembly
Target Audience:
Regulatory authorities, pharmaceutical industry
Period of validity:
Ongoing
Approval Date:
14 May 2025
Date of Changes:
Currently under public consultation
Note:
Context
Year:
2025
Region / city:
Global
Topic:
Pharmaceuticals, Quality Guidelines
Document Type:
Guideline
Organization / Institution:
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Author:
ICH Assembly
Target Audience:
Regulatory authorities, pharmaceutical industry
Period of validity:
Ongoing
Approval Date:
14 May 2025
Date of Changes:
Currently under public consultation
Note:
Context
Year:
2023
Region / City:
Australia
Subject:
Chronic migraine, medicinal product submission
Document type:
Submission for PBS listing
Organization:
Novartis Pharmaceuticals Australia Pty. Limited
Author:
Not specified
Target audience:
Health professionals, pharmaceutical regulatory bodies
Period of validity:
Not specified
Date of approval:
2 July 2018
Date of amendments:
November 2023
Year:
2023
Region / city:
Australia
Topic:
Vedolizumab submission for chronic pouchitis treatment
Document type:
Submission for listing of medicinal product
Agency:
Therapeutic Goods Administration (TGA)
Author:
Takeda Pharmaceuticals Australia Pty. Ltd.
Target audience:
Healthcare professionals, regulatory authorities
Effective period:
From 29 June 2023
Approval date:
29 June 2023
Modification date:
N/A
Year:
2022
Region / city:
Sri Lanka
Topic:
Pharmaceuticals import
Document type:
Invitation for expressions of interest
Organization:
Ministry of Health, Sri Lanka
Author:
Ministry of Health
Target audience:
Pharmaceutical suppliers
Period of validity:
3 months
Approval date:
27th September 2022
Date of amendments:
N/A
Year:
2018
Region / City:
Australia
Topic:
Pharmaceutical Submission, Cancer Treatment
Document Type:
Submission
Organization / Institution:
Takeda Pharmaceuticals Australia Pty Ltd
Author:
Takeda Pharmaceuticals Australia Pty Ltd
Target Audience:
Healthcare professionals, PBAC
Period of Validity:
Ongoing
Approval Date:
23 May 2018
Date of Amendments:
Not specified
Year:
2017
Region / City:
United States
Theme:
Public Law, Pharmaceutical Pricing
Document Type:
Request for Modification
Organization / Institution:
U.S. Department of Veterans Affairs
Author:
Not specified
Target Audience:
Contractors in the pharmaceutical and medical supply industry
Effective Period:
January 15, 2017 or later
Approval Date:
November 2016
Amendment Date:
November 2016
Context:
A regulatory document outlining the procedures for modifying contracts related to pharmaceutical pricing under Public Law 102-585.
Year:
2024
Region / City:
Ratmalana, Sri Lanka
Subject:
Supply, Installation, and Commissioning of Inline Checkweigher Systems
Document Type:
Tender Document
Organ / Institution:
State Pharmaceuticals Manufacturing Corporation (SPMC)
Author:
State Pharmaceuticals Manufacturing Corporation
Target Audience:
Bidders for the supply and installation of checkweigher systems
Period of Action:
September 2024
Approval Date:
2024
Modification Date:
N/A
Year:
2021
Region / City:
Australia
Topic:
Pharmaceutical submission
Document type:
Submission report
Organization:
Novartis Pharmaceuticals Australia Pty Limited
Author:
Novartis Pharmaceuticals Australia Pty Limited
Target audience:
Healthcare professionals, regulatory bodies
Period of validity:
Ongoing
Approval date:
21 August 2002
Date of revisions:
18 December 2009, 11 March 2016, 8 July 2021, 16 July 2021, 29 July 2021
Note:
Contextual description
Year:
2021
Region / City:
Madison, WI
Subject:
Ethnobotany, Biopiracy, Gender and Race Studies
Document Type:
Syllabus
Institution:
University of Wisconsin-Madison
Author:
Ruth Goldstein, PhD
Target Audience:
Undergraduate and Graduate students
Period of Validity:
Fall Semester
Approval Date:
2021
Date of Changes:
Not specified
Year:
2021
Region / City:
Global
Subject:
Procurement
Document Type:
Bidding Document
Organization:
The World Bank
Author:
The World Bank
Target Audience:
Bidders, Contractors, Procurement Officers
Period of Validity:
N/A
Approval Date:
June 2021
Date of Changes:
June 2021
Year:
2020
Region / City:
Australia
Theme:
Pharmaceutical submission, medical treatment
Document Type:
Submission
Organization / Institution:
Takeda Pharmaceuticals Australia Pty Ltd
Author:
Takeda Pharmaceuticals Australia Pty Ltd
Target Audience:
Medical practitioners, gastroenterologists
Period of Validity:
Not specified
Approval Date:
12 May 2020
Modification Date:
Not specified
Registration Status:
Registered by TGA
Clinical Claim:
VDZ SC is as effective as VDZ IV for maintenance treatment in MSUC and severe CD
Indications:
Treatment for moderate to severe ulcerative colitis and Crohn’s disease
Requested Listings:
PBS listing for VDZ SC as maintenance treatment
Prescriber Instructions:
Specific guidelines for initiating subcutaneous therapy
Administrative Advice:
Applications for authorisation under PBS can be made online or by phone
Contextual Description:
A pharmaceutical submission for the approval of vedolizumab (VDZ SC) as a maintenance treatment for moderate to severe ulcerative colitis and severe Crohn’s disease based on a cost-minimisation analysis.
Year:
2017
Sector:
Health
Goods covered:
Pharmaceuticals, Vaccines, Condoms
Document type:
Standard Procurement Document
Procurement stage:
Prequalification
Procurement method:
Request for Bids
Issuing organization:
World Bank
Applicable regulations:
Procurement Regulations for IPF Borrowers
Financing sources:
IBRD, IDA
Initial issue:
July 2016
Revision dates:
July 2016; January 2017; October 2017
Geographic applicability:
World Bank-financed projects
Legal framework reference:
Procurement Regulations for IPF Borrowers, July 2016 as amended
Intended users:
Borrowers and implementing agencies
Copyright status:
Copyrighted; non-commercial use only
Year:
2016
Region / city:
Australia
Theme:
Paediatric-onset Hypophosphatasia (HPP) treatment
Document type:
Application submission
Organ / institution:
Alexion Pharmaceuticals Australasia Pty Ltd
Author:
Alexion Pharmaceuticals Australasia Pty Ltd
Target audience:
Healthcare professionals, Pharmaceutical regulatory bodies
Period of validity:
Ongoing
Approval date:
14 January 2016
Date of amendments:
N/A
Year:
2004
Region / City:
Accra, Ghana
Topic:
Public procurement, healthcare
Document Type:
Tender Document
Organization / Institution:
Public Procurement Board
Author:
Public Procurement Board
Target Audience:
Procurement entities, tenderers
Validity Period:
N/A
Approval Date:
March 2004
Date of Amendments:
N/A
Year:
FY 2023
Region / City:
USA
Topic:
Financial Analysis, Pharmaceutical Valuation
Document Type:
Investment Report
Organization / Institution:
N/A
Author:
N/A
Target Audience:
Investors, Financial Analysts
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2023
Region / City:
Not specified
Subject:
Importing BMC-Compuware License File in ECC
Document Type:
Technical Guide
Organization:
BMC Software
Author:
Not specified
Target Audience:
IT professionals managing enterprise systems
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Note:
Year
Year:
2025-2026
Region / City:
United States
Topic:
Higher education data collection
Document type:
Data standards
Organization:
College Board, Peterson’s, U.S. News & World Report
Author:
Not specified
Target audience:
Higher education institutions, data providers
Period of validity:
2025-2026
Approval date:
Not specified
Date of changes:
Not specified
Year:
2025
Region / city:
Global
Topic:
Pharmaceuticals, Quality Guidelines
Document Type:
Guideline
Organization / Institution:
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Author:
ICH Assembly
Target Audience:
Regulatory authorities, pharmaceutical industry
Period of validity:
Ongoing
Approval Date:
14 May 2025
Date of Changes:
Currently under public consultation
Note:
Context