№ lp_1_30787
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This document provides detailed guidelines and data requirements for the chemical evaluation of active substances in the context of regulatory submissions.
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
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2015
Region / City:
OECD
Topic:
Endocrine disruption, Aromatase inhibition, Reproductive dysfunction in fish
Document Type:
Review report
Organization / Institution:
OECD
Author:
Not specified
Target Audience:
Researchers, Environmental regulators, Toxicologists
Period of validity:
Not specified
Approval Date:
Not specified
Date of revisions:
September 2015
Tracking No:
2023-229-BWCA-002-F
Date:
January 26, 2024
Applicant:
Bayer West-Central Africa S.A.
Organism:
Maize (Zea mays)
Trait:
Resistance to Coleoptera, Tolerance to Glyphosate
Genes:
cp4 epsps, cry3Bb1, DvSnf7
Food and Feed Safety:
Compositional considerations for Maize
Approval History:
Argentina, Australia-New Zealand, Brazil, Canada, Colombia, European Union, Japan, Mexico, Paraguay, Philippines, Republic of Korea, USA, Vietnam
Date of First Approval:
August 06, 2015 (Australia-New Zealand)
Assessment Summary:
Safety and nutritional assessments confirm the event is as safe as its conventional counterpart.
Recommended Terms and Conditions:
Limited to food, feed, and processing use; not for cultivation; compliance with biosafety regulations required.
Year:
2024
Region / city:
OECD countries
Topic:
Private Equity, Health Care
Document Type:
Research Report
Institution:
OECD
Author:
Victoria L. Berquist, Riku Buri, Miika Heinonen, Matias Pietola, Ulrika Winblad, and others
Target Audience:
Researchers, Policymakers, Healthcare Industry Professionals
Period of Validity:
2013-2023
Approval Date:
2024
Date of Changes:
2024
Note:
Contextual Description
Year:
2024
Region / City:
Ghana
Theme:
Genetically Modified Organisms, Food Safety
Document Type:
Risk Assessment Report
Organization:
Technical Advisory Committee (TAC)
Author:
Not specified
Target Audience:
National Biosafety Authority, Regulatory Authorities
Period of Validity:
3 years
Approval Date:
January 26, 2024
Date of Amendments:
None
Document Type:
Data Evaluation Record template
Study Type:
Acute Eye Irritation
Guideline:
U.S. EPA OCSPP 870.2400
OECD Guideline:
405 (IIIM 7.1.5)
PMRA Data Code:
M4.9
Regulatory References:
40 CFR § 160; FIFRA
Issuing Authority:
U.S. Environmental Protection Agency
Related Organizations:
Pest Management Regulatory Agency; Organisation for Economic Co-operation and Development
Compliance Standard:
Good Laboratory Practice (GLP)
Intended Use:
Regulatory data submission and evaluation
Language:
English
Year:
2012
Region / City:
OECD
Theme:
Development Assistance
Document Type:
Annex
Organization:
OECD
Author:
OECD DAC
Target Audience:
Policy makers, statisticians, development professionals
Period of Validity:
2012 and onwards
Approval Date:
2012
Date of Changes:
N/A
Year:
2023
Organization:
Organisation for Economic Co-operation and Development (OECD)
Type of Document:
Compilation / Report
Scope:
International
Participants:
Non-member countries in OECD advisory groups, boards, and projects
Events Covered:
Ministerial meetings, workshops, conferences
Countries Listed:
Brazil, Bulgaria, Croatia, Peru, Romania, India, Indonesia, China, South Africa, Afghanistan, Argentina, Bangladesh, Colombia, Costa Rica, Lithuania, Singapore, etc.
Purpose:
Record of non-member participation in OECD bodies and activities
Update Frequency:
Annual
Document Language:
English
Year:
2024
Region / city:
Ghana
Topic:
Genetically Modified Organisms, Soybean
Document Type:
Risk Assessment Recommendation
Organisation:
Technical Advisory Committee (TAC)
Author:
Technical Advisory Committee (TAC)
Target Audience:
National Biosafety Authority (NBA), Regulatory Authorities
Validity Period:
3 years, renewable
Approval Date:
January 26, 2024
Date of Changes:
N/A
Year:
2016
Date:
April 17, 2016
Location of Session:
Moscow, Russian Federation
Event:
Fifteenth Session of the Working Group on Biochemical and Molecular Techniques and DNA Profiling in Particular
Organization:
International Union for the Protection of New Varieties of Plants (UPOV)
Prepared by:
Office of the Union
Related Organizations:
Organisation for Economic Co-operation and Development (OECD); International Organization for Standardization (ISO); International Seed Testing Association (ISTA); Association of Official Seed Analysts (AOSA)
Document Code:
EBMT/15/5
Document Type:
Working group meeting document
Subject:
Cooperation on biochemical and molecular techniques and DNA profiling in plant variety examination and seed testing
Main Topics:
Joint initiatives; molecular marker techniques; coordination between international organizations; terminology and data exchange
Purpose:
Report on cooperation between OECD, UPOV, ISO and ISTA regarding molecular techniques and outline planned joint activities
Related Bodies:
Technical Committee (TC); Working Group on Biochemical and Molecular Techniques (BMT)
Planned Activity:
Joint OECD/UPOV/ISTA/AOSA Workshop on Biochemical and Molecular Techniques, Paris, 8 June 2016
Status:
Informational document with disclaimer that it does not represent UPOV policies or guidance
Year:
2012
Region:
OECD countries, Latin America
Topic:
Foreign direct investment and financial markets
Document type:
Research paper
Institution:
Not specified
Author:
Not specified
Target audience:
Economists, policymakers, researchers
Period covered:
1990-2010
Data sources:
Cross-country FDI and financial market data
Methodology:
Empirical estimation, statistical analysis
Key variables:
FDI inflows, stock market performance, credit market activity
Comparative focus:
OECD vs Latin American economies
Year:
2024
Region / city:
Global
Topic:
Domestic Revenue Mobilization, Sustainable Development Goals, Tax Reforms, International Cooperation
Document type:
Policy Brief
Organization:
IMF, OECD, WBG
Authors:
IMF, OECD, WBG
Target audience:
Governments, Policymakers, International Organizations
Period of validity:
N/A
Approval date:
N/A
Date of revisions:
N/A
Year:
2024
Region / city:
United Kingdom
Theme:
Organic food certification
Document type:
Form
Organization / institution:
Soil Association
Author:
Soil Association
Target audience:
Companies submitting products for certification
Effective period:
From September 2025
Approval date:
Not specified
Amendment date:
March 2024
Year:
2024
Region / City:
United Kingdom
Subject:
Multi-ingredient product submission form
Document Type:
Form
Organization / Institution:
Soil Association
Author:
Soil Association
Target Audience:
Companies submitting multi-ingredient products
Effective Period:
From September 2025
Approval Date:
Not specified
Amendment Date:
March 2024
Year:
2024
Region / city:
United Kingdom
Topic:
Food & Drink Certification
Document Type:
Form
Institution:
Soil Association
Author:
Soil Association
Target Audience:
Companies sourcing multi-ingredient food products
Period of Validity:
Until September 2025
Approval Date:
March 2024
Date of Changes:
September 2025
Year:
2022
Region / City:
Rwanda
Subject:
Pharmaceutical manufacturing, GMP inspection
Document Type:
Form
Organ / Institution:
Rwanda Food and Drugs Authority
Author:
N/A
Target Audience:
Pharmaceutical manufacturers
Period of validity:
20 June 2022 - 10 October 2025
Approval Date:
20 June 2022
Revision Date:
03 October 2022
Effective Date:
11 October 2022
Review Due Date:
10 October 2025
Year:
2020
Region / City:
Australia
Topic:
Health software, Active ingredient prescribing
Document Type:
Vendor Resource Document
Organization:
Medical Software Industry Association (MSIA)
Author:
MSIA in collaboration with The Australian Government Department of Health
Target Audience:
Prescribing software developers
Effective Period:
2020
Approval Date:
1 December 2020
Amendment Dates:
23/07/2019, 07/08/2019, 15/08/2019, 22/08/2019, 28/08/2019, 10/09/2019, 24/09/2019, 28/10/2019, 31/10/2019, 7/11/2019, 28/11/2019, 5/12/2019, 29/01/2020, 12/02/2020, 24/02/2020, 27/05/2020, 13/08/2020, 26/08/2020, 5/11/2020, 1/12/2020
Note:
Context Description
Note:
Year
Document Type:
Terms and Conditions
Organization:
Innovative Education Ltd.
Target Audience:
Schools
Context:
Terms and conditions document outlining the subscription, delivery, and service details for Classroom Kitchen Ingredient Delivery Service.
Year:
2026
Document type:
Application form
Subject:
Prequalification of Active Pharmaceutical Ingredient (API)
Organization:
World Health Organization Prequalification Team (PQTm)
Applicant:
[Company name from application]
Contact person:
[Name and position from application]
API manufacturer:
[Name and address from application]
API intermediate manufacturer(s):
[Names and addresses from application]
Site Master File (SMF) included:
Yes / No (depending on submission)
GMP compliance evidence:
Included / Requested inspection
Relevant standards:
ICHQ7, ICHQ3D, Pharmacopoeial standards
Other regulatory agencies involved:
EDQM, US FDA, other authorities if listed
Note:
Year
Theme:
Pharmaceutical
Document Type:
Application form
Organization / institution:
World Health Organization (WHO)
Target audience:
Regulatory authorities, pharmaceutical manufacturers
Context description:
A form for submitting an application to WHO for API prequalification, including details on manufacturing sites, GMP compliance, and nitrosamine risk assessment.
Year:
2026
Region / City:
Not specified
Topic:
Health / Antioxidants
Document Type:
Product Information
Organization / Institution:
E. EXCEL
Author:
Not specified
Target Audience:
Health-conscious individuals
Effective Period:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified