Hi all
Just going through the ema minutes again and came across this: My understanding is that tissue therapies could ask for help from the scientific advice anytime over the last 2 1/2 years.
Ancillary medicinal substances in medical devices (section 5)
Although the EMA does not regulate medical devices it can be asked by the relevant authorities (the so-called Notified Bodies) that are responsible for regulating these devices to give a scientific opinion on a medicinal substance contained in a medical device.
Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorisation application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorisation. Following the Agency’s advice increases the probability of a positive outcome.
TIS Price at posting:
11.5¢ Sentiment: None Disclosure: Held
