In March 2012, the UK MHRA and Department of Health issued alerts informing the public of information from the AFSSAPS
suggesting that PIP implants manufactured prior to 2001 might, like the later PIP implants, contain unauthorized silicone filler.
In the case of the Mediator, the Medicines Agency imposed the removal while the AFSSAPS
was responsible for announcing the decision on November 25, 2009.
The 175-page AFSSAPS
report was released yesterday.
Measures taken by selected regularly agencies before and after licensing to assess and control antimicrobial drug resistance * Measure Australia France Therapeutic Goods AFSSAPS
(french Administration, health products Australian safety agency), Commission for Primary drug Drug Evaluation Marketing registration body Committee Authorization Drug resistance advisory EAGAR GTA, CA-SFM, ONERBA resource Licensing Use of supportive Yes Yes PK/PD data Risk assessment Yes Yes After licensing Prescription-only Yes Yes status Community drug Yes No subsidy restrictions Participation in education Yes Yes (e.
French Health Products Safety Agency AFSSAPS
Approves STERRAD(R) Hydrogen Peroxide Gas Plasma Technology for Total Inactivation of Protein-based Infectious Agents Linked to Fatal Brain Diseases
After recalling the principles for awarding the Pharmapack prizes and thanking the jury, Prof Philippe Arnaud, Faculte de Pharmacie, Universite Paris V Rene Descartes, Pharmacist, Hopital Bichat, AFSSAPS
expert, pointed out: As for the awards at previous editions, the jury members, who are independent, have singled out packaging/drug duos placed on the French market between the 1st January and the 31st December 2007, taking all the categories into account and, in particular, medical devices, which are real driving forces behind innovation in the pharmaceutical sector.
The Hyderabad facility has been inspected and approved by various regulatory agencies like DCGI, ANVISA-Brazil, MoH (Turkey), FDA, AFSSAPS
(France), WHO and MHRA.
In February 2012, the Offices of the French medicines agency, AFSSAPS
, were searched by investigators after it allowed the sale of diabetes drug Mediator (benfluorex).
Successfully audited by US FDA, Canada's TPD, Brazil's ANVISA, France's AFSSAPS
, UK's MHRA and more recently Austria's AGES regulatory authorities, Algorithme Pharma conducts over 275 clinical trials per year.
An application was filed for "Operational Pharmaceutical Status" (Statut de laboratoire pharmaceutique exploitant) last November to AFSSAPS
(French Drug Agency) which should be delivered to Novagali in the first half of 2008.
The PX'Pharma facility and equipment have been inspected by AFSSAPS
(France) and comply with the French and European (EMEA) GMP guidelines.
Database of Key Industry Participants: Abbott Diagnostics, Abbott/ i-STAT, Affymetrix, AFSSAPS
, ASSOBIOMEDICA, Association of British Health-Care Industries (ABHI), Axis-Shield, Bauer, Bayer, Bayer Ag, Bayer Corporation, Bayer Diagnostics, Bayer Healthcare, BD Diagnostic systems, Beckman Coulter, Becton Dickinson, Biomerieux, Bio-Rad Labs, Biosite, British In Vitro Diagnostics Association, BVMED, COCIR, Dade Behring, DakoCytomatiom, DeCODE Genetics, Digene, Digene Corporation, DoH, DPC, DPC FRANCE, DrEnger and P EUROM VI Medical Technology, DrEnger Medical AG & Co.