MHRAsafety guidance83% confidence
Clinical trials for medicines: collection, verification and reporting of safety events
Source: MHRA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Shanghai Junshi Bioscience.
Regulatory Analysis
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Supporting Context
- Therapeutic area
- Oncology · Nasopharyngeal Carcinoma
- Sub-indication
- General
Related signal: Phase I Study of JS001sc in Advanced Nasopharyngeal Carcinoma Shows Focus on Safety and Tolerability