Monday Weekly Summary (25.03 – 31.03.2024)
? Monday Weekly Summary: Stay informed with the latest regulatory updates!
In the fast-paced world of regulations, staying updated is key to success. We’ve gathered a comprehensive list of regulatory updates from last week (25.03 – 31.03.2024) to keep you informed about the latest changes in the pharmaceutical industry. Check out the links below for essential insights and ensure compliance with the ever-evolving landscape.
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? Scientific Articles
- Pharmacovigilance and Appropriate Drug Use
- The Reporting Recommendations Intended for Pharmaceutical Risk Minimization Evaluation Studies: Standards for Reporting of Implementation Studies Extension (RIMES-SE)
? Recommendations/Regulations/Guidelines/Instructions/FAQs
- Medical literature monitoring
- Functionalities in support of the medical literature monitoring service User manual: EudraVigilance ICSR Downloads and tracking spreadsheets
- Monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency – Description of the Journal/Reference databases used
- Electronic submission of IND safety reports to FDA
- Message from the President of the Polish HA dated March 27, 2024, on the European Union Reference Laboratories (EURL) in the field of in vitro diagnostic medical devices designated under Regulation (EU) 2017/746.
- Template – Application for transfer of marketing authorisation from transferor to transferee, cover letter
- Regulatory information – adjusted fees for applications to EMA from 1 April 2024
- Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) – human
- Extensions of marketing authorisations: questions and answers
- Type-IA variations: questions and answers
- Type-II variations: questions and answers
- European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
- Post-authorisation safety studies (PASS)
- Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections
- FDA’s Final Guidance on Carcinogenicity Testing of Pharmaceuticals
- EU recommendations for 2024/2025 seasonal flu vaccine composition
- Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials – Scientific guideline
? Reports
- N/A
?Trainings/Presentations/Invitations
- Multi-stakeholder webinar on HMA-EMA Catalogues of real-world data sources and studies – Session 1
- Multi-stakeholder webinar on HMA-EMA Catalogues of real-world data sources and studies – Session 2
- Multi-stakeholder webinar on HMA-EMA Catalogues of real-world data sources and studies – Session 3
- Multi-stakeholder webinar on HMA-EMA Catalogues of real-world data sources and studies – Session 4
- Clinical Pharmacology Guidances Advancing Drug Development and Regulatory Assessment | Role and Opportunities – 05/08/2024
- Real World Evidence – From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies
- System Demo 24Q1
? News/Press Releases
- CDER’s Drug Quality Sampling and Testing Program
- Software Associated with Prescription Drugs: Opportunities to Enhance Safe and Effective Medication Use
- Setting and Implementing Standards for Narrow Therapeutic Index Drugs
?️ Meeting agendas/minutes/summary
- Management Board meeting: 21 March 2024, European Medicines Agency, Amsterdam, the Netherlands, 21 March 2024
- EMA Management Board: highlights of December 2023 meeting
?Product opinion/decisions/updates
- List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)
- List of medicinal products under additional monitoring
- Nitrosamines EMEA-H-A5(3)-1490 – Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products
- Appendix 3 : Enhanced Ames Test Conditions for N-nitrosamines
- List of centrally authorised products requiring a notification of a change for update of annexes
? Other
- N/A
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