China Regulatory Express: 100,000 Get Emergency Use COVID-19 Vaccines
Plus RWE For Pediatric Drug Guidelines
Over 100,000 people in China have already been inoculated with Sinopharm's COVID-19 vaccine under an EUA. Meanwhile, the country's regulatory agency has conducted an internal audit of the vaccines oversight process, and is drawing up guidance on the use of real world evidence for pediatric drugs.
You may also be interested in...
With gene editing making the news again after the recent Nobel Prize for CRISPR, China’s EdiGene has been raising new funds to accelerate its pipeline to the clinic, led by a potential one-time cure for thalassemia and helped by recent regulatory changes.
Given the high number of such trials in the country, China’s National Medical Products Administration has released separate guidelines for industry on the development of gene and cell therapies and gene editing clinical research.
China is nearing the finish line in the coronavirus vaccines race with just “the last kilometer to go”, and its government is already negotiating with the WHO for potential global supplies.