📢 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 (24.06 – 30.06.2024) 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
- Clinical investigation of medicinal products for the treatment of psoriatic arthritis – Scientific guideline
- Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis
- Annex to interim measures regarding notification of pharmacovigilance alerts by marketing authorisation holders under Regulation (EU) 2019/6: contact points
- Clinical Trial Information System (CTIS) – Sponsor handbook
- Clinical Trial Information System (CTIS) structured data form – Notifications and results
- Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products – Scientific guideline
- Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle
- Transfer of MA templates Attachment 4 (Superseded)
- Transfer of MA templates – Attachment 5 (Superseded)
- Transfer of MA templates Attachment 6.1 (Superseded)
- Transfer of MA templates Attachment 6.1.1 (No longer valid)
- Transfer of MA templates Attachment 6.4 (Superseded)
- Paediatric investigation plan (PIP) – Key elements guidance
- Questions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use
- FDA Guidance Provides New Details on Diversity Action Plans Required for Certain Clinical Studies
- Section 503A of the Federal Food, Drug, and Cosmetic Act
- European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
📖 Reports
💡Trainings/Presentations/Invitations
- Joint HMA/EMA Big Data Steering Group Workshop on RWE Methods
- Agenda – Public webinar on pack size submissions: from XEVMPD to product management service (PMS)
- eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course – September 2024, Online, from 10 September 2024 to 12 September 2024
- S4 Biomarkers and companion diagnostics
📰 News/Press Releases
🗓️ Meeting agendas/minutes/summary
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024
- HMPC meeting report on European Union herbal monographs, guidelines and other activities – 27-29 May 2024
- Agenda – PDCO agenda of the 25-28 June 2024 meeting
📋Product opinion/decisions/updates
- List of medicinal products under additional monitoring
- Referral: Lorazepam Macure 4 mg/ml, solution for injection, lorazepam Article 13 referrals CHMP opinion, 27/06/2024
- Surgiflo haemostatic matrix kit – Ferrosan – Procedural steps and scientific information after initial consultation
- FDA alerts health care professionals of significant safety risks associated with cesium chloride
- EU actions to tackle shortages of GLP-1 receptor agonists
- Saxenda (liraglutide) supply shortage
- Trulicity (dulaglutide) supply shortage
📚 Other
#AIDIFY #RegulatoryUpdates #PharmaIndustry #StayInformed #ComplianceMatters