№ lp_1_2_29185
File format: docx
Character count: 15119
File size: 135 KB
This document outlines the response format and instructions for applicants submitting their responses regarding quality, nonclinical, and clinical aspects of medicinal products for regulatory assessments.
Year:
2026
Region / city:
N/A
Subject:
Pharmaceutical regulatory submission
Document type:
Submission guidelines
Authority / institution:
N/A
Author:
N/A
Target audience:
Applicants for pharmaceutical submissions
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2026
Region / City:
International
Theme:
Research Ethics
Document Type:
Standard Operating Procedure (SOP)
Organ / Institution:
ISU-IREB
Author:
ISU-IREB SOP Team
Target Audience:
Researchers, IREB Members
Period of Validity:
Ongoing
Approval Date:
2026-02-03
Date of Changes:
N/A
Year:
2021
Region / city:
N/A
Subject area:
Toxicology
Document type:
Template
Author:
BioCelerate
Target audience:
Researchers, regulatory professionals
Period of validity:
N/A
Approval date:
N/A
Amendment date:
N/A
Note:
Year
Contextual description:
A checklist for the submission of variations related to type II clinical and non-clinical changes to product information in the European market.
Year:
N/A
Region / City:
N/A
Subject:
Toxicology Study Plan/Protocol
Document Type:
Template
Organization / Institution:
BioCelerate
Author:
N/A
Target Audience:
Researchers, Sponsors, and CROs involved in nonclinical studies
Period of Validity:
N/A
Approval Date:
N/A
Modification Date:
N/A
Document Type:
Regulatory guidance
Module:
2.4 Nonclinical Overview
Framework:
Common Technical Document (CTD)
Related Guideline:
M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
Note:
Related Guideline
Guidance for Industry M4S: The CTD — Safety
Subject:
Nonclinical testing strategy, pharmacology, pharmacokinetics, and toxicology
Intended Application:
Registration of pharmaceuticals for human use
Referenced Standards:
Good Laboratory Practice (GLP)
Scope:
Evaluation of pharmacologic, pharmacokinetic, toxicologic, and impurity data
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