EMA Relocates Drug Evaluations to EU Member States
The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.
The European Medicines Agency (EMA) announced on April 11, 2018 that it has completed the relocation of more than 370 centrally authorized products previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to new rapporteurs or co-rapporteurs from the European Union’s 27 member states as well as Iceland and Norway. Marketing authorization holders will be informed about the new rapporteurships by the end of April 2018.
The relocation, due to the United Kingdom’s exit from the European Union, followed a methodology developed by EMA’s working groups on committees’ operational preparedness for human and veterinary medicines. The redistribution covered drugs in the post-authorization stage with marketing authorizations.
EMA’s approach to the redistribution took into account the current and specific expertise of the various members in the EU regulatory network. The type of product was also taken into consideration.
“Generic medicines, for example, were allocated to national competent authorities who traditionally have participated less in EMA evaluations but have indicated that they would like to increase their involvement with such medicines. Clusters of products with the same international non-proprietary name (INN) and/or belonging to the same marketing authorization holder have been allocated to a single rapporteur in order to facilitate review of post-authorization procedures and ultimately improve efficiency within the network,” the agency stated in a press release.
The transfer of knowledge from the UK to the new rapporteurs will be done once marketing authorization holders are informed of the changes. Full responsibility of the drug products by the new rapporteurs will begin March 30, 2019 after the UK withdraws from the EU.
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.
