📢 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 (20.05 – 26.05.2024) 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.
🌟 Scientific Articles
- Trends in Use and Evidence of Adherence to Risk Evaluation and Mitigation Strategy Pregnancy Testing Requirements for Thalidomide, Lenalidomide, and Pomalidomide in the USA, 2000–2020
- A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
- IRIS guide for applicants – How to create and submit scientific applications, for industry and individual applicants
- The ICH M12 Guideline reaches Step 4 of the ICH Process
- ICH M14 draft Guideline reaches Step 2 of the ICH process
- The ICH Q2(R2)/Q14 Introductory Training Presentation is now available on the ICH website
- Anonymisation report form instructions
- Anonymisation report form template
- Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) – Frequently asked questions
- European medicines network designated as WHO listed authority
📖 Reports
💡Trainings/Presentations/Invitations
- 2024 05 21 Let’s Code Together
- Transition Your Clinical Trials to CTIS
- Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval
- Statistical Considerations for Premarketing Risk Assessment
- Facilitating Generic Drug Product Development through Product-Specific Guidances
📰 News/Press Releases
- CTIS newsflash – 17 May 2024
- Ground-breaking progress made in Member State negotiations on amendments to the International Health Regulations (IHR)
🗓️ Meeting agendas/minutes/summary
📋Product opinion/decisions/updates
- List of centrally authorised products requiring a notification of a change for update of annexes
- Giapreza – direct healthcare professional communication (DHPC)
📚 Other
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