For the second time in less than a month, the European Commission (EC) has updated its questions and answers (Q&As) document on the incoming clinical trials regulation, this time explaining what it means to have a trial authorized subject to conditions.
The Q&A makes clear upfront that an initial clinical trial application, substantial amendment or an addition of a member state concerned can be authorized, authorized subject to conditions or rejected.
For this nebulous “subject to conditions” category, the EC explains that such authorizations are “restricted to conditions which by their nature cannot be fulfilled at the time of that authorisation.” And setting a condition is “only possible in case of an application with a positive benefit/risk balance. This means that if the benefit-risk balance is not positive at the time of the authorisation, the application should be rejected.”
Such conditions can include a “request additional data not available at the time of the authorisation, e.g. data needed for later trial parts, but not preventing the start of the trial,” or to “indicate aspects that the sponsor need to fulfill after the authorisation, e.g. submission of minutes of the safety data monitoring board meetings.”…