!Kung,
Regarding easing the approval process, the US and EU agreed to reciprocity on production facility inspections. PhRMA touts it as a big time saver, but IMO plant inspections are usually not on the critical path for approval (i.e., not the rate determining step) though it will probably save a little money/documentation. Any regulatory affairs folks out there want to comment? (see below)
On a different note, Rman's absence has turned this into far too dry a thread. Therefore, I feel it my duty to point out that Zonagen has again shown efficacy of their product in a second PIII trial for Male Erectile Dysfunction; maybe that will get the Rocket back in the game. Anybody care to comment on their technology? What is it, shredded and solubilized back issues of Playboy, Penthouse and Hustler?
biowa
**********************************************************
WASHINGTON, June 13 /PRNewswire/ -- "Patients in the United States and Europe will get safe and effective new drugs sooner thanks to an agreement announced today," said Alan F. Holmer, President of the Pharmaceutical Research and Manufacturers of America in a statement applauding a Mutual Recognition Agreement concluded between the U.S. and the European Commission.
The Mutual Recognition Agreement (MRA) eliminates various regulatory barriers for a range of products, from boats to telecommunications. For pharmaceuticals, the agreement means that the United States and the European Union will recognize each other's inspections of pharmaceutical manufacturing facilities. Previously, inspectors from each jurisdiction had to inspect every factory where a drug imported into that jurisdiction was manufactured. This added cost for both the governments and the manufacturers and oftencaused delays in the availability of medicines.
"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 faster," said Holmer. "And the money saved by avoiding duplication of effort can be used to increase research on cures forcurrently incurable diseases."
Holmer praised the work of Commerce Secretary William Daley, U.S. Trade Representative Charlene Barshefsky, Acting FDA Commissioner Michael Friedman and their negotiating staffs in securing this wide-ranging agreement on a hostof complex issues.
PhRMA Internet address: phrma.org
SOURCE Pharmacuetical Research and Manufacturers of America
CONTACT: Alixe Glen of the Pharmacuetical Research and
Manufacturers of America, 202-835-3460 |
