№ lp_1_01010
File format: docx
Character count: 65503
File size: 463 KB
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.
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2025
Region / city:
EU
Topic:
Health Technology Assessment
Document Type:
Guidance
Organization / Institution:
HTA CG
Author:
European Commission
Target audience:
Professionals in Health Technology Assessment
Validity period:
From 28 NOVEMBER 2025
Approval date:
28 NOVEMBER 2025
Amendment date:
Not specified
Year:
2023
Region / city:
Singapore
Topic:
Pharmaceutical manufacturing and regulatory requirements
Document type:
Regulatory guideline
Organization:
Health Sciences Authority
Author:
Health Sciences Authority
Target audience:
Pharmaceutical manufacturers, regulatory professionals
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A
Year:
2026
Region / City:
Singapore
Subject:
Pharmaceutical Manufacturing and Regulatory Compliance
Document Type:
Regulatory Guidelines
Organization:
Health Sciences Authority (HSA)
Author:
Health Sciences Authority
Target Audience:
Pharmaceutical Manufacturers, Regulatory Affairs Professionals
Period of Validity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
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:
2015
Region / City:
Burlington, NJ
Topic:
Fleet Management Software
Document Type:
User Guide
Organization:
Dossier Systems, Inc.
Author:
Dossier Systems, Inc.
Target Audience:
Fleet Maintenance Managers, IT Administrators
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Year:
2022
Region / City:
SADC region
Topic:
Medicine Regulatory Harmonization
Document Type:
Position Paper
Organization / Institution:
SADC Medicines Regulatory Forum (SADC MRF)
Author:
T. Sithole, G. Mahlangu, S. Walker, S. Salek
Target Audience:
Regulatory authorities, pharmaceutical industry, applicants
Period of Validity:
Up to 12 months from issuance of recommendation
Date of Approval:
Not specified
Date of Amendments:
Not specified
Note:
Year
Topic:
Academic Promotion and Tenure
Document Type:
Instructional Guidelines
Organization / Institution:
Auburn University
Target Audience:
Faculty, Department Chairs, University Administrators
Context:
Instructional guidelines for faculty members preparing their dossiers for promotion and tenure evaluations.
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
Note:
Year
Subject:
Medicine Formularies, Health Policy
Document Type:
Form, Application
Institution:
Ministry of Health
Author:
Applicant (Consultant, Specialist, Medical Officer, Pharmacist)
Target Audience:
Healthcare Professionals, Drug and Therapeutic Committee
Context:
Form used to propose the inclusion of a medicine or indication from the Ministry of Health Medicines Formulary into an institution’s Medicines Formulary for approval by the institution’s Drug and Therapeutic Committee.
Year:
Not specified
Region / City:
Malaysia
Topic:
Pharmaceutical registration and formulary listing
Document Type:
Application Form
Organization / Institution:
Ministry of Health Malaysia
Author:
Not specified
Target Audience:
Pharmaceutical companies, regulatory authorities
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Amendments:
Not specified
Year:
2025
Region / city:
European Union
Topic:
Health Technology Assessment (HTA)
Document type:
Guideline / Supplementary material
Author:
HTA CG
Target audience:
Health technology assessors, clinical researchers
Period of validity:
Not specified
Approval date:
28 November 2025
Modification 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:
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