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
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
