Monday Weekly Summary (18.03 – 24.03.2024)
? 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 (18.03 – 24.03.2024) 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.
? Scientific Articles
? Recommendations/Regulations/Guidelines/Instructions/FAQs
- Introduction to MedDRA Labeling Grouping (MLG)
- ICH E2D Guidelines update
- Environmental risk assessment of medicinal products for human use – Scientific guideline
- Template for pharmacovigilance assessment information sharing
- Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD)
- Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products
- Template – Application for transfer of marketing authorisation from transferor to transferee, cover letter
- Template – Application for transfer of marketing authorisation from transferor to transferee, attachment 1
- Template – Application for transfer of marketing authorisation from transferor to transferee, attachment 2
? Reports
- EMA Management Board: highlights of March 2024 meeting
- Stakeholder engagement highlights 2022
- CTIS newsflash – 22 March 2024
?Trainings/Presentations/Invitations
- Electronic Common Technical Document (eCTD) vendor workshop
- 2024 03 20 Let’s Code Together
- Biosimilar medications: As identical twins explain, biosimilars have the same benefits (30 sec.)
- Resistome Tracker Tutorial
- NARMS Now: Integrated Data Tutorial
- Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes
- Expanding Generic Drug Access Through International Engagements
? News/Press Releases
- Call for urgent agreement on international deal to prepare for and prevent future pandemics
- Some CBD products are being sold with unproven claims saying they can treat or prevent diseases
- Membership list: HMA-EMA joint Big Data Steering Group
- Scientific Explorer – Frequently Asked Questions
- WHO urges investments for the scale up of tuberculosis screening and preventive treatment
- Accelerating stakeholder collaboration to enhance the clinical trials environment in the EU
?️ Meeting agendas/minutes/summary
- Agenda of the CHMP meeting 18-21 March 2024
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2024
- Agenda of the 123rd meeting of the Management Board : 21 March 2024
?Product opinion/decisions/updates
- Referral: Micrazym and associated names, porcine pancreas enzymes Article 29(4) referrals CHMP opinion, 21/03/2024
- Withdrawn application: Ongentys, 12/03/2024
- New antibiotic to fight infections caused by multidrug-resistant bacteria
- Withdrawn application: Orencia, 19/02/2024
- Withdrawn application: Adcetris, 23/02/2024
- Article 57 product data
- FDA Approves First Gene Therapy for Children with Metachromatic Leukodystrophy
? Other
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