№ lp_1_2_26244
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Proposal for a regulation on improving the availability, security of supply, and accessibility of critical medicinal products in the EU, with an amendment concerning military service exemptions for strategic projects in case of armed conflict.
Year:
2025
Region / City:
Brussels
Topic:
Critical Medicines, Health Safety, EU Legislation
Document Type:
Opinion
Organization:
European Economic and Social Committee
Author:
Pietro Francesco DE LOTTO, Veselin MITOV, Elżbieta SZADZIŃSKA
Target Audience:
EU policymakers, health and medicine stakeholders
Period of Validity:
2025
Approval Date:
6 June 2025
Amendment Date:
6 June 2025
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2022
Jurisdiction:
European Union
Legal basis:
Regulation (EU) 2022/2554
Document type:
Commission Implementing Regulation
Issuing body:
European Commission
Subject matter:
ICT third-party risk management
Sector:
Financial services
Scope:
Financial entities and ICT third-party service providers
Regulatory framework:
Digital operational resilience
Related institutions:
European Banking Authority; European Insurance and Occupational Pensions Authority; European Securities and Markets Authority
Relevance:
EEA
Organisation:
Internet Watch Foundation (IWF)
Type of document:
Policy submission
Subject:
Prevention and combat of child sexual abuse material online
Geographical scope:
European Union
Related legislation:
Proposed Regulation laying down rules to prevent and combat child sexual abuse
Referenced regulation:
Interim Regulation (temporary derogation from the e-Privacy Directive)
Referenced institution:
European Commission
Referenced body:
National Center for Missing and Exploited Children (NCMEC)
Year referenced:
2021
Statistics cited:
361,026 reports assessed; 252,194 confirmed as child sexual abuse; 62% of removed content hosted in EU Member States
Key themes:
Voluntary detection, mandatory detection orders, legal certainty, safety by design, end-to-end encryption, EU Centre, National Coordinating Authorities, transparency and reporting obligations
Year:
2023
Region / city:
Akure, Nigeria
Topic:
Poultry nutrition, Egg quality, Feed additives
Document type:
Research article
Organization / institution:
Federal University of Technology, Akure
Author:
Omotoso O. B., Samuel D. A., Oso T. S., Olamide E. I., Akande O. A., Okhankhuele O. T., Ogunwande I. O., Oludahunsi O. F.
Target audience:
Researchers, poultry farmers, academics
Effective period:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2023
Region / City:
European Union
Subject:
Insurance, Regulation, Public Administration
Document Type:
Regulation
Institution:
European Commission
Target Audience:
Member States, Regulatory Authorities, Insurance and Reinsurance Sector
Period of Validity:
Not specified
Date of Approval:
Not specified
Date of Amendment:
Not specified
Context:
A regulation outlining technical standards for the treatment of exposures to regional governments and local authorities as exposures to central governments within the context of the Solvency II framework.
Year:
2022-2023
Region / City:
Nedumangad, Trivandrum
Subject:
Water Supply, Public Works
Document Type:
Selection Notice
Authority / Institution:
Kerala Water Authority
Author:
Assistant Executive Engineer
Target Audience:
Contractor / Construction Companies
Execution Period:
45 days from the order date
Approval Date:
23-07-2022
Amendment Date:
Not specified
Year:
2026
Region / city:
United Kingdom
Topic:
Good Manufacturing Practice, Advanced Therapy Medicinal Products (ATMPs)
Document type:
Consultation response
Organization / institution:
NHS Advanced Therapy Medicinal Products Working Party
Author:
Anne Black
Target audience:
Pharmaceutical professionals, regulatory bodies, academic researchers
Period of validity:
Not specified
Approval date:
Not specified
Amendment date:
Not specified
Year:
2024
Region / City:
European Union
Theme:
Health Technology Assessment
Document Type:
Guidance Document
Author:
HTA Coordination Group (HTACG)
Target Audience:
Health Technology Developers, Regulatory Authorities, Medical Researchers
Period of Validity:
Ongoing
Approval Date:
28 November 2024
Date of Last Change:
N/A
Context:
Guidance document for filling in the joint clinical assessment (JCA) dossier template for medicinal products, intended for use by health technology developers and regulatory bodies.
Year:
2017
Regulation:
EU No 536/2014
Document type:
Template
Topic:
Investigational Medicinal Products (IMP)
Regulatory reference:
Article 62(1) of Regulation (EU) No 536/2014
Manufacturer:
Not specified
Certification authority:
Qualified Person (QP)
Target audience:
Manufacturers, sponsors, regulatory bodies
Purpose:
Harmonisation of batch release certification
Approval date:
Not specified
Modification date:
Not specified
Context:
Template for certification of investigational medicinal products batch release for clinical trials, ensuring compliance with EU regulations on Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
Note:
Year
Theme:
Medicinal product registration
Document type:
Application form
Organization:
Swissmedic
Target audience:
Pharmaceutical companies, Regulatory authorities
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:
2016
Region / city:
EU
Theme:
Pharmaceutical Regulation
Document Type:
Guideline
Organization:
EFPIA
Author:
Sini Eskola
Target audience:
Regulatory authorities, pharmaceutical professionals
Period of validity:
Not specified
Approval date:
Not specified
Date of amendments:
Not specified
Note:
Year
Document Type:
Quality Technical Agreement
Year:
2022
Region / City:
European Union
Theme:
Orphan medicinal products, market exclusivity
Document type:
Template
Organization:
European Medicines Agency
Author:
CMDh
Target Audience:
Applicants for marketing authorization of orphan medicinal products
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
July 2022
Note:
Region / City
Document Type:
Validation Checklist
Contextual description:
A validation checklist for medicinal product applications within the Decentralized Procedure (DCP) process.
Year:
2024
Region / city:
EU
Subject:
Health Technology Assessment
Document type:
Annex
Organization:
HTA CG
Author:
European Commission
Target audience:
Health Technology Assessment bodies, regulatory bodies
Effective period:
October 2024
Approval date:
28 November 2024
Modification date:
None
Year:
2025
Region / city:
Switzerland
Theme:
Medicinal product authorisation
Document type:
Regulatory submission form
Organisation / institution:
Swissmedic
Author:
Swissmedic
Target audience:
Pharmaceutical companies
Period of validity:
From 01.10.2025
Approval date:
Pending
Amendment date:
N/A
Year:
2025
Region / City:
Switzerland
Topic:
Medicinal Product Authorisation
Document Type:
Application Form
Institution:
Swissmedic
Author:
Not specified
Target Audience:
Regulatory authorities, Pharmaceutical companies
Period of validity:
From 01.01.2025
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2023
Region / City:
Global
Subject:
Clinical trials, Teletrial Model, Investigational Medicinal Product
Document Type:
Standard Operating Procedure (SOP)
Institution:
Teletrial Primary Site Pharmacy
Author:
Not specified
Target Audience:
Clinical trial staff, Teletrial site personnel
Period of validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2016
Region / city:
Europe
Topic:
Good Manufacturing Practice for Advanced Therapy Medicinal Products
Document type:
Consultation response
Organization / institution:
EBE/EFPIA
Author:
EBE/EFPIA
Target audience:
Pharmaceutical industry, Regulatory authorities
Period of validity:
Indefinite
Approval date:
28-Jun-2016
Modification date:
N/A