📢 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 (22.07 – 28.07.2024) 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
- The PrescIT platform: An interoperable Clinical Decision Support System for ePrescription to Prevent Adverse Drug Reactions and Drug-Drug Interactions
- Knowledge Graphs in Pharmacovigilance: A Scoping Review
- Adopting STOPP/START Criteria Version 3 in Clinical Practice: A Q&A Guide for Healthcare Professionals
- The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System
- Optimal Significance Levels and Sample Sizes for Signal Detection Methods Based on Non-constant Hazards
📝 Recommendations/Regulations/Guidelines/Instructions/FAQs
- Medical Devices and In Vitro Diagnostics Regulations: publication of a consensus statement from the EU Competent Authorities to the EU Commission
- Guidance Development and Regulatory Assessment of Generic Topical and Dermal Drug Products – 10/03/2024
- Records of data processing activity for digital business cards (QR code)
- Maximum residue limits (MRL)
- Poorly extractable and/or non- radiolabelled substances – Scientific guideline
- Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
- Draft guideline on the chemistry of active substances – Revision 1
- Data quality framework for medicines regulation
- Use of raw data in medicine evaluation
- Mutual recognition agreements (MRA)
- Development and manufacture of oligonucleotides – Scientific guideline
- Chapter 3.II: XEVPRM user guidance of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
- Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment
📖 Reports
- N/A
💡Trainings/Presentations/Invitations
- Pack size submissions: from XEVMPD to PMS – 11 July 2024
- PMS API Training – 8 July 2024
- LinkedIn live on ACT EU
- ACT EU consolidated advice pilots: information and training webinar for Applicants
📰 News/Press Releases
- N/A
🗓️ Meeting agendas/minutes/summary
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024
- Agenda of the CHMP meeting 22-25 July 2024
- Agenda – PDCO agenda of the 25-28 June 2024 meeting
- Agenda – PDCO agenda of the 23-26 July 2024 meeting
- Agenda of the HMPC meeting 22-24 July 2024
📋Product opinion/decisions/updates
- Union List of Critical Medicines: XEVMPD/PMS entries
- New product information wording – Extracts from PRAC recommendations on signals adopted at the 13-16 May 2024 PRAC
📚 Other
- N/A
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