IRIS PHARMA AND GLP ACCREDITATION

French regulatory authority:
In 1995, Iris Pharma was granted a GLP accreditation for preclinical units by the French health products safety agency (the Agence française de sécurité sanitaire des produits de santé, AFSSAPS).

FDA:
The European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have been collaborating for many years in the sector of pharmaceuticals. This collaboration takes the form of multilateral work, including the International Conference on Harmonisation (ICH), and bilateral work.

A preclinical study conducted with Iris Pharma in accordance with French standards of Good Laboratory Practice (GLP) is also acceptable in the USA for evaluation as part of product applications submitted for approval.

• Memorandum of understanding between French ministry of social affairs and national solidarity office of pharmaceuticals and medicines and the U.S. Food and Drug Administration Department of health and Human Services (1986) http://www.fda.gov/
• Summary of the FDA-Related Elements of the " Agreement on Mutual Recognition Between the United States of America and the European Community" (1997) http://www.fda.gov/

IRIS PHARMA AND INSPECTIONS

Iris Pharma is regularly inspected:

• For GLP compliance for drugs by the French drug agency (AFSSAPS : Agence française de sécurité sanitaire des produits de santé http://www.afssaps.fr/)
• For animal care and husbandry by the department of veterinary services
• For radiolabeled material by the nuclear security direction (ASN : Autorité de sureté Nucléaire http://www.asn.fr/)
• For GLP compliance for chemical products by the French association in charge of accreditation, certification and inspection of laboratories (COFRAC: http://www.cofrac.fr/)
• By our clients