Dr. Jenny Sharpe

Senior Scientific Writer, Centre for Innovation in Regulatory Science

Three key trends in regulatory approvals of new medicines

A new study by the Centre for Innovation in Regulatory Science (CIRS) has shown that despite regulatory convergence over the last 20 years, there are still differences in approval times across global regulatory agencies. The following article summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2011-2020. Three […]

2019 trends in regulatory approvals of new medicines

A study by the Centre for Innovation in Regulatory Science (CIRS) has identified trends in approvals of New Active Substances (NASs) by six major regulatory authorities1 , focusing on 2019 as well as the period from 2010 to 2019. In addition to tracking the number of approvals and the time to approval, the study also […]

Applying regulatory flexibility in the age of COVID-19

A study by the Centre for Innovation in Regulatory Science has found that there are numerous regulatory routes that can be used to assess and authorise medical products during a public health emergency or pandemic. Although yet to be used extensively, these Emergency Use Pathways (EUPs) offer the regulatory flexibility needed to ensure that medical […]