📢 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 (09.09 – 15.09.2024) 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
- Questions and answers on the guideline on the environmental risk assessment of medicinal products for human use
- Questions and answers regarding co-processed excipients used in solid oral dosage forms
- EMA guidance on the use of medicinal products for treatment and prophylaxis in case of exposure to biological agents used as weapons of terrorism, crime or warfare
- EMA guidance on the use of medicinal products for treatment in case of exposure to chemical agents used as weapons of terrorism, crime, or warfare
- Questions and answers – Info session on web-based electronic Application Form (eAF) add package
- Member states contact points for translations review
- Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder – Revision 1
📖 Reports
- N/A
💡Trainings/Presentations/Invitations
📰 News/Press Releases
🗓️ Meeting agendas/minutes/summary
- Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (18 September 2024)
- Minutes – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (26 June 2024)
- Second European Medicines Agency and COCIR bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 7 October 2024
- Third European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 7 November 2024
- Agenda of the Medicine Shortages SPOC Working Party meeting – 11 September 2024
- Agenda – Information session on the pilot for expert panels’ advice for orphan medical devices
- Minutes of the PRAC meeting 8-11 July 2024
📋Product opinion/decisions/updates
- Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA)
- Timetable: Post-authorisation measures (PAMs) assessed by PRAC – ATMP
- Timetable: Periodic safety update report (PSUR) and PSUR single assessment (PSUSA) – Advanced therapy medicinal products (ATMPs)
- Timetable: Safety signal – Assessment of responses to request for supplementary information (RSI) – ATMP
- Ocaliva – referral
📚 Other
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