№ lp_1_26513
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Character count: 7634
File size: 46 KB
This position paper outlines a proposal to improve the efficiency of the ZaZiBoNa joint review process in the SADC region by introducing a dossier processing fee and adjusting the operational model.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
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:
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
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:
2017
Region / City:
N/A
Theme:
Medical Device Regulation
Document Type:
Fee List
Organization / Institution:
Notified Body XXXX
Target Audience:
Manufacturers of medical devices
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Year:
2024
Region / City:
Glen Rose, Texas
Topic:
Probate Fees
Document Type:
Notice
Organization / Institution:
Somervell County Clerk
Author:
Michelle Reynolds, County Clerk
Target Audience:
General public, legal professionals
Period of validity:
From 1/1/2024
Date of approval:
Not specified
Date of changes:
Not specified
Year:
2025
Region / City:
Singapore
Topic:
Customs, Inter-Bank GIRO, Payment Procedures
Document Type:
Application Form
Agency / Organization:
Singapore Customs
Author:
Singapore Customs
Target Audience:
Entities with business transactions involving Singapore Customs
Effective Period:
Ongoing
Approval Date:
Not stated
Date of Amendments:
Not stated
Year:
2012
Region / City:
United States
Topic:
Corporate Social Responsibility, Audit Fees, Audit Opinions
Document Type:
Academic Paper
Institution:
George Mason University, City University of Hong Kong, The Chinese University of Hong Kong, The University of Tennessee
Authors:
Long Chen, Bin Srinidhi, Albert Tsang, Wei Yu
Target Audience:
Academics, Researchers, Auditors, Policymakers
Period of Effectiveness:
2000-2008
Approval Date:
March 30, 2012
Date of Amendments:
N/A
Court:
United States Bankruptcy Court
District:
Western District of Missouri
Document type:
Motion
Case type:
Bankruptcy
Governing rule:
Local Rule 2016-2(E)
Moving party:
Attorney for the debtor(s)
Debtor(s):
Enter debtor(s) name
Case number:
Enter Case No.
Fee categories:
Defense of motions for relief from the automatic stay; defense of motion to dismiss for failure to make plan payments; motions to suspend or abate payments; motion to vacate and reinstate following dismissal for default in plan payments; hearings; copy expenses; postage expenses
Response period:
Twenty-one (21) days from the date of notice
Filing method:
Electronic filing via ECF or mail
Court address for responses:
United States Bankruptcy Court, 400 E. 9th St., Room 1510, Kansas City, MO 64106
Certification:
Certificate of Service included