Monday Weekly Summary (01.04 – 07.04.2024)
? 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 (01.04 – 07.04.2024) 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.
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? Scientific Articles
? Recommendations/Regulations/Guidelines/Instructions/FAQs
- CMDh Q&A – Pharmacovigilance Legislation
- Transfer of marketing authorisation: questions and answers
- Electronic submission of IND safety reports to FDA
- Assessment templates and guidance
- Day 80 assessment report – Clinical template with guidance – Rev.04.24 Revamp
- Procedural advice on Zero Day MR Procedures
- Minutes of the Meeting of a subgroup of CMDh with Interested Parties dedicated to LoSC and publication of PI updates
- List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation
- Marketing authorisation templates
- Data Integrity for In Vivo Bioavailability and Bioequivalence Studies
- Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry
- Exporting Investigational New Drugs
- Export Requirements for Unapproved Drugs
- Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) – Scientific guideline
? Reports
- N/A
?Trainings/Presentations/Invitations
- 3Rs Working Party (3RsWP) plenary meeting – Public session on the 2024 work plan
- Multi-stakeholder webinar on HMA-EMA Catalogues of real-world data sources and studies – Session 1
- Multi-stakeholder webinar on HMA-EMA Catalogues of real-world data sources and studies – Session 2
- Multi-stakeholder webinar on HMA-EMA Catalogues of real-world data sources and studies – Session 3
- Multi-stakeholder webinar on HMA-EMA Catalogues of real-world data sources and studies – Session 4
? News/Press Releases
?️ Meeting agendas/minutes/summary
?Product opinion/decisions/updates
- Pseudoephedrine-containing medicinal products – referral
- List of signals discussed at PRAC since September 2012
- List of medicines currently in PRIME scheme
? Other
- Traineeship – Frequently asked questions (FAQs)
- DSUR Submissions and Fees Update from MHRA
- Medical devices
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