CMDh Steps In As Firm Finds No Takers To Replace UK As Reference Member State
The coordination group of EU member state regulators was recently presented with an exceptional case where all concerned member states initially refused to become the new reference member state for a drug evaluated by the UK. The group explained that 'unscheduled switches' can result in unforeseen workload, resulting in member states refusing to take on the RMS role.
You may also be interested in...
The EMA has completed the reallocation to the EU27 member states of more than 370 centrally authorized drugs for which the UK was rapporteur or co-rapporteur. The move has been necessitated by Brexit, which means the UK will no longer play an active role in new drug evaluations at the EMA.
EU member state regulators have issued updated advice for marketing authorization holders wanting to change their reference member state for medicines evaluated through the mutual recognition and/or decentralized procedures. The document notes that Brexit is now an accepted reason for a switch of CMS, and explains how to make the switch in cases where all the strengths of the drug are not approved in any concerned member state.
In the first of a two-part article on transparency provisions for the new EU clinical trial portal, the Pink Sheet reports on aspects that sponsors must consider to protect commercially confidential information in their clinical trial applications. The second article will look at the approach taken by Merck and discuss outstanding hot topics in relation to transparency and CTIS.