Global Regulators Collaborate to Improve Access to Safe Drugs
The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.
The European Medicines Agency met with regulators from the European Union and Africa in a workshop held in Malta from March 2-3, 2017 to discuss how the different agencies can work together to improve the availability safe and effective drugs to areas outside of Europe. The workshop was organized by EMA and the Maltese Presidency of the European Union with the support of the Bill & Melinda Gates Foundation and the World Health Organization (WHO).
Workshop attendees discussed how EMA could conduct scientific assessment of drugs or vaccines for use outside of the EU in line with European legislation and in cooperation with WHO. These assessments could increase access to safe medications to patients in low- and middle-income countries.
“Effective medicine regulation plays a crucial role in every health system to ensure that all medicines are safe, effective and meet approved standards,” said EMA Executive Director Guido Rasi, in a press release. “I am confident that by increasing our two-way dialogue and the information on regulatory tools available we can strengthen international collaboration and benefit patients.”
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.
