BRUSSELS, September 9, 2011 /PRNewswire/ —

The Board of the European Fine Chemicals Group (EFCG) is
delighted to announce that today it agreed to ratify the proposal
of the US Food and Drug Administration (FDA) to put forward a
legislative package, designed with the help of EFCG and US industry
representatives, to deliver into US law a new Generic Drug User
Fees Act (GDUFA).

GDUFA requires the FDA to commit to significantly improve and
enhance its regulatory activities for the benefit of global generic
drug providers and US generic drug users, in exchange for the
global generics industry providing FDA with $299 million in user
fees each year over the next 5 years.

The key benefits for drug providers will be faster and more
predictable regulatory review times, including dealing with the
backlog of applications, and parity of inspections between domestic
and foreign sites for both finished dosage form (FDF) and active
pharmaceutical ingredient (API) manufacturers.

Guy Villax, CEO of Hovione and an EFCG Board member, who led the
EFCG negotiating team, commented “the outcome of these negotiations
are epoch-making for our industry and, if adopted, will go a long
way to deliver on EFCG’s major objective to level the playing field
for its members. Regulators’ weak enforcement has made
non-compliance a major competitive advantage. We congratulate FDA
for leading the way to find solutions that both protect the patient
and stop unfair competition.”

Notes for editors:

Generic drugs are those containing off-patent APIs made
available to patients via a doctor’s prescription. Over the counter
(OTC) drugs available to patients without prescription are excluded
from GDUFA.

For public minutes of industry meetings with the FDA see the FDA
website at

http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm256662.htm

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