The guidance outlines the main steps to take in preparation for submission and a list of documents required for the main1 types of paediatric submissions
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European Medicines Agency. EMA’S GUIDE ON ADVANCED THERAPY MEDICINAL PRODUCTS. Non-Clinical Development Flowchart. Version 1.0 – 29 November 2021
Published by EMA
Gene TherapyMedical ProductsNon-Clinical Development SchemeEMA’s guide to help developers of gene therapy medicinal products (GTMPs) and cell-based medicinal products (CBMPs) navigate the most important regulatory requirements during the non-clinical development phase
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European Medicines Agency. Committee for Advanced Therapies (CAT). Procedural Advice on the Provision of Scientific Recommendation on Classification of Advanced Therapy Medicinal Products in Accordance with Article 17 of Regulation (EC) No 1394/2007. EMA/CAT/99623/2009 Rev.2. 5 November 2021
Published by EMA
Comittee for Advanced TherapiesScientific RecommendationThe purpose of this procedure is to allow applicants to clarify whether a given product based on genes, cells or tissues meets the scientific criteria which define ATMPs, in order to address questions of borderline with other areas such as cosmetics or medical devices, which may arise as science develops.
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European Medicines Agency. Committee for Advanced Therapies (CAT). Guideline on Quality, Non-Clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells. 3 November 2020. EMA/CAT/GTWP/671639/2008 Rev. 1
Published by EMA
Clinical AspectsGenetically Modified CellGuidelineNon-ClinicalQualityGuideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
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Clinical Trials Information System (CTIS) – Sponsor
Handbook
Published by EMA
Clinical Trials Information SystemCTISHandbookThis document is a compilation of key guidance, technical information, recommendations and
references for getting ready for use of CTIS
This document is the IRIS guide for applicants
(how to create and submit scientific applications, for industry and individual
applicants)
EMA_Checklist Transfer Orphan Designation_2020
Published by EMA
Orphan Medicinal ProductSponsorsTransferThis document makes a checklist for sponsors applying for the transfer of Orphan
Medicinal Product (OMP) designation
Guideline for the Notification of Serious Breaches of
Regulation (EU) No 536/2014 or the Clinical Trial Protocol
Published by EMA
assessmentclinical trial participantsClinical TrialscomplianceprotocolRegulation (EU) No 536/2014Serious Breachesservice providerSponsorsThis document describes the guideline for the notification of serious breaches of
Regulation (EU) No 536/2014
Assent or Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in
Europe
Published by EMA
Assent GuidanceInformed GuidancePaediatric Clinical TrialsThis document is the guidance about Assent or Informed Consent for Paediatric Clinical Trials with Medicinal Products in
Europe
This document is the IRIS guide to registration
Preliminary requirements for all IRIS submissions, including
substance and Research Product Identifier registration
