New drugs will reach patients sooner as a result of a new agreement between the United States and the European Union.
New drugs will reach patients sooner as a result of a new agreement between the United States and the European Union.
The Mutual Recognition Act removes various regulatory barriers for a wide range of products, including pharmaceuticals.
The agreement was developed primarily by the U.S. Food and Drug Administration, the U.S. Department of Commerce and the European Commission, a governing office of the European Union.
According to the agreement, the United States and participating European countries will recognize each others' inspections of pharmaceutical manufacturing facilities. This agreement will reduce costs for governments and manufacturers and ultimately translate into fewer delays in the availability of new medicines.
Previously, inspectors from each jurisdiction had to inspect every factory where an imported drug was manufactured.
"At a time when patients everywhere are waiting for cures for AIDS, Alzheimer's, cancer and a host of other diseases, this agreement will help get new treatments to patients fast," said Alan Holmer, president of the Pharmaceutical Research and Manufacturers of America, in support of the cooperative effort.
"The money saved by avoiding duplication of effort can be used to increase research on cures for currently incurable diseases," Holmer said. PR
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.