Monday Weekly Summary (22.01 – 28.01.2024)
? 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 (22.01 – 28.01.2024) 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
- Utilizing temporal pattern of adverse event reports to identify potential late-onset adverse events
- Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project
? Recommendations/Regulations/Guidelines/Instructions/FAQs
- ICH Q14 Analytical procedure development – Scientific guideline
- Maximum residue limit (MRL) evaluation for biological substances – Scientific guideline
- Clinical evaluation of medicinal products intended for treatment of hepatitis B – Scientific guideline
- QRD Appendix V – Adverse-drug-reaction reporting details
- Guidance on remote GCP inspections during public health threats, political conflicts, natural disasters, or other major disruptions
- Guidance on remote GCP inspections during the COVID-19 pandemic
- PSUSA nationally authorised products template
- QRD PSUR annex IV template
- Major update of the SME user guide
- Support to SMEs
- User guide for micro, small and medium-sized enterprises
- Guideline on the clinical evaluation of anticancer medicinal products – Revision 6
? Reports
- N/A
?Trainings/Presentations/Invitations
- Compounding Quality Center of Excellence | Self-Guided Online Trainings
- Compounding Quality Center of Excellence | Cross-Sector Stakeholder Group
- 2024 01 23 Advanced MedDRA Coding
- Network users training for Regulatory Procedure Management 1st roll-out on IRIS
- MedDRA MSSO Mission
- Multi-stakeholder workshop on Data Quality Framework for Adverse Drug Reaction reporting, Online, 1 March 2024
? News/Press Releases
- Multi-annual artificial intelligence workplan 2023-2028: HMA-EMA joint Big Data Steering Group
- Clinical data publication
- Work plan for the CVMP Novel Therapies & Technologies Working Party (NTWP) 2024
- Decision of the Management Board amending budget No. 01, amending appropriations in budget 2024
?️ Meeting agendas/minutes/summary
- Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 January 2023
- Committee for Herbal Medicinal Products (HMPC): 29-31 January 2024, European Medicines Agency, Amsterdam, the Netherlands, from 29 January 2024 to 31 January 2024
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024
?Product opinion/decisions/updates
- Appendix 1: Acceptable intakes established for N-nitrosamines
- Submission deadlines for paediatric applications 2024-2026
- Start of Union reviews adopted during the CHMP meeting of 22-25 January 2024
- EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
- EMA confirms measures to minimise the risk of serious side effects with medicines containing pseudoephedrine
- Aprotinin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation – EMEA/H/N/PSR/S/0030
- Pravastatin : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation – PSUSA/00002500/202303
- Shortage of Rybelsus (semaglutide) supply shortage
? Other
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