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With the recent implementation of Clinical Trial Regulation (CTR), replacing Clinical Trial Directive (CTD) in the European Union (EU), it is crucial to have a thorough understanding of Clinical Trials Information System (CTIS). CTR will become fully applicable to all ongoing clinical trials involving medicinal products in the EU on January 31, 2025, marking the hard stop for CTD. To facilitate the transition, the European Medicines Agency (EMA) has published this updated EU CTIS Sponsor Handbook (v4.0). This handbook provides information needed to navigate the CTIS in creating and submitting clinical trial information as required by CTR and addresses key questions on CTIS by providing a compilation and references to key guidance, technical information, recommendations, training materials, and supportive documentation. https://lnkd.in/eAy49C-J #EMA #EuropeanUnion #DrugDevelopment #CTIS #CTD #CTR #RegulatoryAffairs #MedicalWriting #BioPharma

The European Union (EU) offers several incentives for medicines that have been granted an orphan designation by the European Commission, (some comparable to those provided by the FDA): ➡ Protocol Assistance: Scientific advice tailored specifically for orphan medicines. ➡ Centralized Assessment: All designated orphan medicines are evaluated through a single application to the European Medicines Agency (EMA), leading to one opinion and one decision from the European Commission, valid across all EU Member States. ➡ Market Protection: Authorized orphan medicines enjoy ten years of market exclusivity. ➡ Reduced Fees: Discounts are available for regulatory activities, including protocol assistance, marketing authorization applications, pre-authorization inspections, post-approval changes, and annual fees. These incentives support the development and availability of crucial orphan medicines within the EU. Source: https://lnkd.in/guNntpt8

Navigating Changes in EU QPPV/RP Regulations https://lnkd.in/dZ8G5tHM An essential guide for managing EU Qualified Person for Pharmacovigilance (QPPV) and Responsible Person (RP) role transitions within pharmaceutical organizations. Learnings: 1️⃣ EMA notification is required within 10 days of a QPPV/RP change. Role transitions involve detailed steps in the EMA Account Management Portal, necessitating careful documentation. 2️⃣ Role validation includes comprehensive identity checks and confirmation of EU/EEA residency for compliance. 3️⃣ Continual maintenance of trained personnel for ICSRs and XEVPRMs submissions is mandatory. Summary: The EMA document EMA/503895/2018 is a critical resource for Marketing Authorisation Holders, Sponsors, and National Competent Authorities engaged in registering or changing an EU QPPV or RP. It outlines the procedural steps necessary for role assignment and removal, emphasizing the importance of rapid communication with the EMA and strict adherence to identity verification. Organizations must ensure that they have suitably trained personnel available at all times, highlighting the operational challenges and compliance significance in pharmacovigilance. #EudraVigilance #Pharmacovigilance #RegulatoryCompliance #QPPV #EUQPPV #EMA

Interpreting the latest EMA EU QPPV and RP changes. The European Medicines Agency (EMA) has issued new documentation for Marketing Authorisation Holders (MAHs), Sponsors (both commercial and non-commercial), and National Competent Authorities (NCAs) about the registration or change of EU Qualified Persons for Pharmacovigilance (EU QPPVs) and Responsible Persons (RPs). The document, released on May 15th, outline the requirements and procedures for these roles. Key points from the guidelines include: 1.     Notification Deadline: Any changes to the EU QPPV or RP roles must be reported to the EMA within 10 calendar days. This process involves detailed steps in the EMA Portal and requires careful documentation. 2.     Declaration Requirement: A declaration must be made by the EU QPPV or RP confirming that the organization has a suitably trained person for submitting Individual Case Safety Reports (ICSRs) and XEVPRMs. 3.     Role Validation: Validation of these roles includes thorough identity checks and confirmation of EU/EEA residency for compliance. 4.     Additional Documents: There are specific additional documents required for both commercial and non-commercial sponsors. In summary, the new EMA/503895/2018 document is essential for MAHs, NCAs, and Sponsors to ensure the rapid communication of these changes with the EMA. It requires trained personnel to manage them and comply with the strict pharmacovigilance requirements and identity verification. The full document is with this post, and can also be accessed from the EMA here: https://lnkd.in/dgyAwz43 Delta PV can assist, manage, and advise on these changes and potential impacts, along with comprehensive consulting and services provision for MAHs and sponsors worldwide. Information about our pharmacovigilance solutions here: https://lnkd.in/gjAusNrF Information about our LITSIS literature screening system here: https://lnkd.in/gDJRDzj6 Please share this post to spread the news and help Delta PV keep growing. Delta PV creates lean, efficient, and effective pharmacovigilance and safety solutions across Europe, CIS, EAEU, Africa, MENA, and APAC. See how we can support you at www.deltapv.com #EUQPPV #pharmacovigilance #EMA #qualitymanagement #pvtechnology

EMA JUST RELEASED ‼️ Clinical Trials Information System (CTIS) - Sponsor Handbook A compilation of key guidance, technical information, recommendations, and references for getting ready for the use of CTIS 💠Executive summary💠 The aim of the #EMA CTIS Sponsor Handbook (#Handbook) is to provide #clinicaltrial (#CT) sponsors representing #pharmaceuticalindustry, #SME (small and medium-sized enterprises), academia, research organisations and other clinical trial sponsor organisations with the information they need to navigate the Clinical Trials Information System (#CTIS) - to create and submit clinical trial information to the member states of the European Union as required by the #ClinicalTrialRegulation [CTR: Regulation (EU) No 536/2014]. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU/EEA, via CTIS. CTIS contains the centralised EU portal and #database for clinical trials foreseen by the Regulation. The Handbook addresses key questions on CTIS and provides a compilation and references to key guidance, technical information, recommendations, training materials, and supportive documentation to facilitate the submission and assessment of CTAs and additional information during the lifecycle of a trial. It has been developed by the European Medicines Agency (EMA) in collaboration with representatives of industry stakeholders. The Handbook will be revised as more information becomes available, or system functionalities are updated. It is best used in conjunction with the many references to which it points, for example, Volume 10 of the publication ‘The rules governing medicinal products in the European Union’ that contains guidance documents applying to clinical trials (#EudraLex - Volume 10 - Clinical trials guidelines). https://lnkd.in/d6jzV9fk If you like this post follow me on LinkedIn #ClinicalTrialsInformationSystem #CTIS #SponsorHandbook #EMA

The European Medicines Agency (EMA) has issued a timely reminder to applicants and marketing authorisation holders regarding the impending adjustment of fees, scheduled to take effect on 1 April 2024, excluding pharmacovigilance procedures. This adjustment aligns with the annual practice of the European Commission, which meticulously calibrates fees in accordance with the inflation rate within the European Union for the preceding year, as evidenced by the 2023 inflation rate of 3.4%. The comprehensive details of the revised fee structure have been promptly disseminated by the EMA following the adoption of Commission Regulation (EU) 2024/848 on 14 March 2024. Notably, the Agency's Management Board, in its March 2024 meeting, decisively endorsed the implementation of the regulation. Importantly, while fees for pharmacovigilance procedures remain unaffected in 2024, due consideration is given to Regulation (EU) 568/2024, slated to come into effect on 1 January 2025, ensuring stability and predictability in regulatory processes. #EMA #fees #regulation #pharmacovigilance #marketingauthorization https://lnkd.in/e43xbeCg

The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) have jointly published Q&As addressing quality and GMP aspects for PRIME and Breakthrough Therapy programs. This document provides insights into regulatory thinking, but does not constitute formal guidance. Key points include: 🔷Considerations for specifications with limited clinical data 🔷Approaches to concurrent process validation 🔷Alternatives for determining shelf-life 🔷GMP aspects when using investigational facilities for launch This collaboration indicates alignment between EMA and FDA on expedited programs, potentially streamlining development for crucial therapies. The document emphasizes the importance of early communication with authorities. While this document does not change regulatory requirements, it offers valuable insights into how EMA and FDA are approaching quality and GMP challenges in expedited development programs. It represents an important step towards harmonizing approaches between these major regulatory bodies, potentially benefiting both industry and patients by facilitating faster development of critical therapies without compromising on quality and safety standards. Link to the EMA–FDA joint Q&As: https://lnkd.in/dqdEazXd #EMA #FDA #PRIME #Breakthrough #expediatedapproval

EMA UPDATE: From January 1st, 2025, EMA is implementing new fees impacting Marketing Authorisation Holders, covering pharmacovigilance activities such as PSURs and PASS protocols, as well as ongoing support for legislation, literature monitoring, and Eudravigilance. MAHs must now navigate updated working arrangements outlined in the latest EMA document. Stay informed to ensure compliance and operational readiness in pharmacovigilance. #Pharmacovigilance #EMAUpdate #RegulatoryCompliance

ClinRegs has updated the United Kingdom (UK) profile. "The United Kingdom profile in ClinRegs has been reviewed and updated with the following information: * Updated Medicines and Healthcare Products Regulatory Agency (MHRA) guidance on a new notification scheme when applying for authorization to conduct a clinical trial (See Scope of Assessment and Submission Process) * MHRA guidance on common issues identified during the clinical trial application process (See Submission Process) * MHRA guidance on regulation and licensing for advanced therapy medicinal products (See Regulatory Authority, Manufacturing & Import, and Specimen Import & Export) * Updated regulatory fees payment requirements (See Regulatory Fees) * Health Research Authority (HRA) guidance outlining standard conditions for sponsors and investigators on the conduct and management of clinical trials (See Initiation, Agreements & Registration) * HRA Participant Information Quality Standards and Participant Information Design and Review Principles which includes guidance for the participant information sheet (See Documentation Requirements) * Principles, fact sheet, and other resources from 2023 and 2024 from the UK Department for Science, Innovation and Technology and the International Trade Association on the UK-US Data Bridge (See Personal Data Protection) * National Health Service resources for the DigiTrials program launched in 2023 that supports clinical trial researchers with secure data about potential participants (See Initiation, Agreements & Registration) "For a detailed listing of sources added or revised during this update, see the UK updates page." #NIAID #ClinRegs #UnitedKingdom #UK #MHRA https://lnkd.in/eTcUTRjc

📢 Exciting News from EMA! 🚀 The European Medicines Agency (EMA) has released the draft Guideline on Quality, Non-Clinical, and Clinical Requirements for Investigational Advanced Therapy Medicinal Products (ATMPs) in Clinical Trials. Let’s dive into the details: 🔍 Key Points: Scope: This guideline provides comprehensive guidance for both exploratory and confirmatory clinical trials involving ATMPs. Multidisciplinary Approach: It covers aspects related to development, manufacturing, quality control, and both non-clinical and clinical development of ATMPs. Regulatory Context: The guideline aligns with Regulation (EC) No 536/2014, emphasizing the protection of subjects’ rights, safety, dignity, and well-being. Trial Phases: Unlike other product types, ATMP development often involves less distinct phases. The focus here is on exploratory trials. Confirmatory Trials: These are crucial for obtaining pivotal data for a marketing authorization application (MAA). Early Phase Considerations: Developers must assess if clinical trial results adequately support later MAA submissions. Existing Guidelines: For confirmatory trials, existing quality, non-clinical, and clinical marketing authorization guidelines should be considered. 📚 Access the Full Guideline: Guideline on Quality, Non-Clinical, and Clinical Requirements for Investigational ATMPs Let’s continue advancing excellence in ATMP development! 🌟💡 #EMA #ATMPs #ClinicalTrials #RegulatoryGuidance