Many companies are hesitant to perform clinical studies on children due to the risks and ethical issues that can arise. This is why the European Medicines Agency (EMA) is looking into revising and reforming the product class waivers to allow companies to test new drugs in pediatrics before they are to be approved.
In order to make sure the new waivers will be approved, they must meet the standards made by the Pediatrics Regulation. These standards are that companies have to meet the pediatric investigation plan or meet one of the three waivers given by the Pediatric Regulations.
To read more, check out Michael Mezher’s article in RAPS about the EMA’s revised process, click here.