UK Pioneers Adaptable Licensing for Orphan Medicines: What It Means for Patients & Manufacturers
Автор: The Open World Channel
Загружено: 2025-11-12
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Описание:
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is developing a groundbreaking framework for orphan medicines, allowing personalized treatments for rare diseases before full regulatory approval. This video explores the proposed changes, including flexible licensing, iterative reassessments, and the use of real-world data. We'll discuss the potential benefits for patients, manufacturers, and the UK's position as a leader in rare disease treatment. Experts weigh in on the challenges, such as pricing negotiations with NICE, and the need for alignment between regulatory and health technology assessment processes.
Key Points Covered:
MHRA's new approach to orphan medicine licensing
Benefits for patients with rare diseases
Impact on manufacturers and drug development
Challenges and considerations: pricing, data collection, and international collaboration
The future of rare disease treatment in the UK
Keywords: orphan medicines, rare diseases, MHRA, UK, personalized medicine, regulatory framework, NICE, drug development, healthcare innovation
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