Regulatory Updates
Page 2 • 12 itemsTrack global pharma regulatory policy changes, FDA, EMA, and other agency guidelines impacting drug development and market access. Stay ahead.
Continuous Manufacturing in Pharmaceuticals: EU Regulatory Insights & Innovation
Discover how continuous manufacturing is transforming pharmaceutical production, with key EU regulatory insights and innovations for drug safety and efficiency.
MHRA Post-Brexit Drug Approval: Key Divergences from EMA in Oncology
This article examines the MHRA's post-Brexit drug approval framework for oncology, focusing on significant divergences from the EMA's processes.
MHRA post-Brexit regulatory pathways: What You Need to Know
Explore the essential MHRA post-Brexit regulatory pathways for drug approval, ensuring compliance and understanding for pharmaceutical professionals.
EU Pharmaceutical Legislation Reform: Impact on Orphan Drug Development & Market Exclusivity
The EU's pharmaceutical legislation reform aims to enhance orphan drug development and market exclusivity, significantly influencing treatments for rare diseases.
EMA Updated Guidelines 2026: Conditional Marketing Authorizations & Accelerated Assessments
Explore the EMA's 2026 updated guidelines on Conditional Marketing Authorizations and Accelerated Assessments, enhancing drug approval processes for urgent medical needs.
PRAC Guidelines Liver Injury: What You Need to Know
Learn about the latest PRAC guidelines on liver injury, focusing on drugs like Paracetamol, to ensure safe and effective pain management.
AI Drug Discovery EU: Accelerating Rare Disease Therapies via COMP & EMA
Discover how AI technology is transforming drug discovery for rare diseases, enhancing the development of therapies under the EU's COMP and EMA frameworks.
EMA AI System for Faster Drug Safety Signal Detection
The EMA's innovative AI system accelerates drug safety signal detection, ensuring timely responses to potential risks associated with medications.
European Commission Blockchain Pilot Enhances Pharmaceutical Supply Chain Security
The European Commission's blockchain pilot aims to bolster the security of the pharmaceutical supply chain, ensuring safer distribution of critical drugs like Xarelto.
Real-World Evidence in EU: Leveraging EHRs for Regulatory Decisions
This article delves into the role of real-world evidence from electronic health records in shaping regulatory decisions for drugs in the EU, improving healthcare delivery.
CHMP Positive Opinion Immunotherapy: Expanded Use in Advanced Lung Cancer
The CHMP's positive opinion on [Drug Name] marks a significant step towards expanded immunotherapy options for patients with advanced lung cancer.
EMA Conditional Approval CAR-T Therapy for Relapsed B-Cell Lymphoma
The EMA has granted conditional approval for CAR-T therapy, offering new hope for patients with relapsed B-cell lymphoma.