Monday Weekly Summary (19.02 – 25.02.2024)
? 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 (19.02 – 25.02.2024) 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
- Non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies for the prevention and treatment of COVID-19 – Scientific guideline
- Procedural advice on the accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6
- The ICH E2D(R1) draft Guideline presentation available now on the ICH website
- Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) – Frequently asked questions
- Fees payable to the European Medicines Agency
- Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition
- Extended EudraVigilance Medicinal Product Report Message step-by-step guide: Insert of a development medicinal product
- Opinions and letters of support on the qualification of novel methodologies for medicine development
- Updated guideline on DHPC dissemination from Polish HA
? Reports
- Multi-agency report highlights importance of reducing antibiotic use
- Orphan medicines figures 2000-2023
- Annual report on the use of the special contribution for orphan medicinal products – 2023
?Trainings/Presentations/Invitations
- CTIS Training materials – Latest updates
- Clinical Trials Information System: training and support
- 2024 02 21 What’s New with MedDRA V27.0 and the MSSO
- The ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management” Module 8 Training Material is now available on the ICH Website.
- Network users training for Regulatory Procedure Management 1st roll-out on IRIS
? News/Press Releases
- Clinical Trial Information System (CTIS) evaluation timelines
- Committee for Advanced Therapies (CAT): Work Plan 2024
- Signal Management Review Technical (SMART) Working Group
- Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2024
- Membership list: HMA-EMA joint Big Data Steering Group
- Infographic – Orphan Medicines in the EU
- FDA Science, Research, and Collaboration Advance Generic Medicines
- Paediatric Formulation Operational Expert Group
- Member States consider proposed amendments to the International Health Regulations with discussions on equity to continue
- Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
?️ Meeting agendas/minutes/summary
?Product opinion/decisions/updates
- Eldisine (vindesine) supply shortage
- FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)
- Referral: Ibuprofen NVT, ibuprofen Article 29(4) referrals Procedure started, 22/02/2024
- Start of Union reviews adopted during the CHMP meeting of 19-22 February 2024
- Orphan medicines figures 2000-2023
- Valproate : PRAC non-interventional imposed PASS final study report assessment report – EMEA/H/N/PSR/J/0043
- Valproate : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation – EMEA/H/N/PSR/J/0043
- Valproate: DHPC distributed in Poland
- Article 57 product data
- Correction to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
? Other
N/A
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