EMA Wants to Know if Pharma is Ready for Brexit
The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.
The European Medicines Agency announced on Jan. 23, 2018 that it was performing a survey to see if pharmaceutical companies are ready for the United Kingdom’s withdrawal from the European Union, also known as Brexit. The survey will also ask companies to identify any concerns they may have.
Specifically, EMA plans to use the survey to identify companies that may need help addressing concerns that have risen from Brexit. EMA and the European Commission will also use survey results to plan for needed resources. The agency hopes the survey may also urge companies that have not yet taken action regarding Brexit-related issues to start doing so.
The survey is being sent to marketing authorization holders located in the UK, or companies who have quality control, batch release, and/or import manufacturing sites or a qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) in the UK. Companies will be asked about their plans to submit transfers, notifications or variations to their marketing authorizations in the context of Brexit.
The deadline for completing the survey is Feb. 9, 2018. Results will be shared with the European Commission and a summary will be published on EMA’s website.
Source: EMA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
