Regulacje i polityka gospodarcza · 18.10.1996

Mutual Recognition Agreement (MRA); Public Meeting; Availability

The Food and Drug Administration (FDA) (Office of External Affairs, Office of International Affairs; Office of Policy; Office of Operations, Office of Regulatory Affairs; and the Centers for Biologics Evaluation and Research, Drug Evaluation and Research, and Veterinary Medicine) is announcing a public meeting to provide information about discussions with the European Union (EU) related to a possible agreement to exchange inspectional information on good manufacturing practices and quality controls for human biologicals and human and animal drugs. At a meeting held on March 31, 1995, FDA committed to keeping the public informed about the progress of these negotiations and to receiving comments on FDA's proposal for an MRA. FDA is also announcing the availability of the document entitled ``FDA Proposal for an Agreement With the European Union Concerning the Mutual Recognition of Inspections to Determine Adherence to Good Manufacturing Practices for Pharmaceuticals Including Biologicals.''