FDA [to 4 March 2017]
FDA News Release
Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union
March 2, 2017
The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
The amended agreement represents the culmination of nearly three years of U.S. Food and Drug Administration and EU cooperation as part of the Mutual Reliance Initiative and will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.
“The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs,” said Dara Corrigan, FDA’s associate commissioner for global regulatory policy…
What’s New for Biologics
:: Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Public Workshop Transcript (PDF – 622KB) Posted: 3/3/2017
:: February 23, 2017 Approval Letter – RotaTeq (PDF – 48KB) Posted: 3/3/2017
:: February 16, 2017 Summary Basis for Regulatory Action – VARIVAX (PDF – 152KB) Posted: 2/27/17