Scientific Advice Adherence Reduces Approval Time by Months, Analysis Shows
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows.
The analysis, by European Medicines Agency staff and the agency’s Scientific Advice Working Party, shows that companies that complied with the agency’s recommendations won approval, on average, in 367 days versus the usual 428.
Both the EMA and FDA encourage companies to meet with regulatory staff early in the drug development process, and this new analysis underscores the advantage of doing so.
The analysis also found that clinical trials are twice as likely to be approved if the sponsor heeds scientific advice early on. Not only do those trials have higher success rates, but they face fewer major objections during assessment, resulting in shorter overall review time.
The likelihood of getting marketing authorization is roughly 85 percent when a clinical trial’s design is acceptable at the time of scientific advice or when a deficiency is changed to conform to recommendations, the analysis says. By comparison, sponsors that don’t follow scientific advice on modifying a deficient trial design have only a 41 percent success rate.
The researchers reviewed applications from 2008 to 2012. According to the EMA, two out of three clinical development plans submitted to the agency had trial designs that wouldn’t have generated the data needed to assess a drug’s benefits and risks.
“Regulatory watch: Impact of scientific advice from the European Medicines Agency” can be viewed at www.fdanews.com/04-15-EMA-Analysis.pdf. — Jonathon Shacat