Monday Weekly Summary (15.01 – 21.01.2024)
? 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 (15.01 – 21.01.2024) 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
- A Risk-Based Approach for Safety Case Follow-up of Adverse Event Reports in Pharmacovigilance
- Withdrawn 2.0-update on withdrawn drugs with pharmacovigilance data
- Generic pharmaceuticals, regulatory aspects, bioequivalence investigation, and perception
- Histology independent drug development – Is this the future for cancer drugs?
- Introducing a core dataset for real-world data in multiple sclerosis registries and cohorts: Recommendations from a global task force
- Validation of a Natural Language Machine Learning Model for Safety Literature Surveillance
? Recommendations/Regulations/Guidelines/Instructions/FAQs
- Orphans: Regulatory and procedural guidance and forms
- Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) – Frequently asked questions
- IRIS guide for applicants – How to create and submit scientific applications, for industry and individual applicants
- Applying for orphan designation
- 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
- Chapter 3.I: Technical specifications of the Detailed guidance on the electronic submission of information on medicinal products for human use by marketing authorisation holders to the EMA
- Guidance on paediatric submissions
- Quality of medicines questions and answers: Part 2
- Risk Evaluation and Mitigation Strategies (REMS)
- Product-specific bioequivalence guidance
? Reports
?Trainings/Presentations/Invitations
- 2024 01 16 MedDRA Coding Basics
- What does the FDA do after drugs are approved?
- How does the FDA approve new drugs?
- What is FDA’s role in regulating drugs?
? News/Press Releases
- WHO releases AI ethics and governance guidance for large multi-modal models
- Membership list: HMA-EMA joint Big Data Steering Group
?️ Meeting agendas/minutes/summary
- Second European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 29 November 2023
- Clinical Trials Information System (CTIS) sponsor end user training programme – February 2024, European Medicines Agency, Amsterdam, the Netherlands, from 12 February 2024, 09:00 (CET) to 15 February 2024, 13:30 (CET)
- Joint HMA/EMA multi-stakeholder workshop on Patient Registries
?Product opinion/decisions/updates
- List of centrally authorised products requiring a notification of a change for update of annexes
- Prolia (denosumab): Drug Safety Communication – FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease
- Integrilin (eptifibatide) supply shortage
- Applications for new human medicines under evaluation: January 2024
? Other
- Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages
- Member states contact points for review of national versions of the content of mobile scanning and other technologies
- Contact details of national competent authorities for requests to use a sticker to place the Unique Identifier on the outer/immediate packaging of centrally approved products
- Policy on the determination of the condition(s) for a paediatric investigation plan (PIP) / waiver (scope of the PIP / waiver)
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