CTD creates review backlog in UK
The UK MHRA admits to delays in the processing of marketing
applications because of a huge number of files submitted ahead of
new EU legislation.
German reforms pass first hurdle
The government of Germany has had its controversial health reform
policy voted in by the country's parliament with a comprehensive
US report on fake drugs this week?
The US Food and Drug Administration (FDA) is set to release an
additional interim report later this week on the issue of drug
EU to soften REACH requirements?
The European Commission has stepped back from requiring the
industry to test thousands of chemicals already used and sold in
Europe, according to an environmental group.
UK benefiting from German reform?
Healthcare reform and cost containment affecting the rest of Europe
are making the UK increasingly attractive to the branded
Australian pharma woes continue
Australian Pharmaceutical Industries follows Pan Pharma as license
to make products is revoked; government is planning crackdown on
the drug industry
Legislation drives Kyorin investment
Japan's Kyorin Pharmaceuticals has revealed that it will build a
new formulation plant at its Noshiro facility in Akita prefecture,
in response to revision to the Pharmaceutical Affairs Law.
Swiss expansion for Ferring
Ferring Pharmaceuticals has unveiled plans to invest €90 million in
a state-of-the-art production site in Saint-Prex in Switzerland.
Big hitters bash biogenerics
An October conference on biogenerics will see research-based
biopharmaceutical companies and their generic rivals battle to win
the hearts and minds of regulators.
FDA plans to amend 21 CFR Part 11 rules
The US Food and Drug Administration has issued its final guidance
document describing its current thinking regarding the scope and
application of 21 CFR Part 11 on electronic records and electronic
signatures; also unveils a series...
GSK starts energy reduction programme
GlaxoSmithKline has enlisted the aid of the UK government in a
program aimed at reducing energy expenditures at six primary
Germany industry group slams reforms
The German government's health care system reform proposals cast
fundamental doubts over Germany's future as a research location,
says VFA chief.
Deal finally reached in WTO access talks
The World Trade Organisation's executive has finally broken
deadlock in a deal to give some of the world's poorest countries
access to cheap drugs.
UK relaxes salt/ester rules for generics
The UK MHRA will allow salt and ester variants of active drugs to
be submitted for approval as generics using abridged applications,
following the EU's lead.
German health reforms drive out Pfizer, Merck
US pharmaceuticals major Pfizer is considering moving some of its
activities in Germany to the UK due to government health reforms;
meanwhile, Merck & Co has shelved plans to open a new R&D
facility in the country.