The QC lab is now fully operational, having been authorized by the
Agenzia Italiana Del Farmaco (AIFA).
The major public health organizations spending in analytical laboratory services include the Food and Drug Administration (U.S.), European Medicines Agency (U.K.), Federal Institute for Drugs and Medical Devices (Germany), Agence francaise de securite sanitaire des produits de sante (France),
Agenzia Italiana del Farmaco (Italy), the Spanish Medicines and Health Products Agency (Spain), Central Drugs Standard Control Organization (India), China Food and Drug Administration, and Pharmaceuticals and Medical Devices Agency (Japan).
Key players in this market include Agence franaise de scurit sanitaire des produits de sant (France),
Agenzia Italiana del Farmaco (Italy), Central Drugs Standard Control Organization (India), China Food and Drug Administration, European Medicines Agency, Federal Institute for Drugs and Medical Devices (Germany), Pharmaceuticals and Medical Devices Agency (Japan), The Food and Drug Administration and The Spanish Medicines and Health Products Agency (Spain).
The company has filed a Clinical Trial Application (CTA) with Italy's drug regulator, the
Agenzia Italiana del Farmaco (AIFA), to conduct a Phase I/II clinical trial in Italy of Trappsol Cyclo for the treatment of Niemann-Pick Disease Type C.
In Europe and the United States, all kinds of cell preparations that are administered to patients following ex vivo culturing are classified as medicines, and monitored by drug agencies such as the Food and Drug Administration, the European Medicines Agency and, in Italy, the
Agenzia Italiana del Farmaco or AIFA.
Alimera Sciences, a United States-based biopharmaceutical company, has received marketing authorisation from the Italian Medicines Agency (
Agenzia Italiana del Farmaco) for ILUVIEN.
ILUVIEN's approval was awarded by the Italian Medicines Agency (
Agenzia Italiana del Farmaco).
Swiss pharmaceutical company Basilea Pharmaceutica AG today announced that its Toctino (alitretinoin) has been approved by the Italian Drug Agency (
Agenzia Italiana del Farmaco [AIFA]).