Roche plant falls foul of FDA rules
Roche's Burgdorf plant making insulin pumps has serious regulatory
compliance problems, said the FDA, which could block import of the
products unless resolved.
EU states taken to ECoJ over biotech
European Commission refers eight EU member states to the European
Court of Justice over their alleged failure to implement legal
protection of biotech inventions.
BASF outlines plan for a greener future
BASF has put forwards environmental and safety standards that will
see it comfortably meet and exceed the pledges for greenhouse gas
emissions laid down by the Kyoto Protocol. The firm stresses the
need for a voluntary system of control,...
EU and Japan seek to align GMP
The European Union and Japan have agreed that there is still a lot
of work to be done before a system of mutual recognition of Good
Manufacturing Practice standards can be put in place.
Commission responds to G10 report
The European Commission has issued its long-awaited response to the
G10 Medicines Report, intended as a blueprint for improving the
European pharmaceutical industry's competitiveness while ensuring
high levels of public health...
Child-safety standards probed by CPSC
The US Consumer Product Safety Commission has started a review of
its criteria to determine whether drug packages meet its
Forum to mull UK labelling guidance
A conference on 1 July will provide an update on the UK Medicines
and Healthcare products Regulatory Agency Best Practice Guidance on
the Labelling and Packaging of Medicines
Policy continuity needed to speed up orphan drug development
While the procedure for designating drugs for orphan diseases has
improved dramatically in the EU, further progress must be made,
says EU biotech group
UK government mulls nanotechnology
The UK has launched a new study to examine in detail the benefits
and risks of nanotechnology and make sure that any necessary
regulatory framework is in place early on
Trained staff key to manufacturing QC
As regulators increase their scrutiny of manufacturing and quality
control, the key to avoiding non-compliance notices lies in
well-trained, knowledgeable personnel, says new report.
China places duty on phenol imports
China has implemented anti-dumping measures against imports of
phenol, a crystalline compound used in pharmaceuticals, resins and
Rapid microbe testing a must for industry
A meeting organised by the UK Medicines and Healthcare products
Regulatory Agency has heard calls for rapid microbiological methods
to be used routinely in the drug industry
Pharma firms risking fines for manufacturing neglect
Pharmaceutical company mergers and acquisitions plus industry-wide
cost cutting has squeezed investment into manufacturing, which may
lead to GMP non-compliance and fines, warns a new report.
EU clinical trials regs could damage uk
The UK BioIndustry Association has serious concerns that the EU
Clinical Trials Directive could have a negative impact on the
attractiveness of the UK as a location for clinical research.
Schering-Plough cuts deal with FDA on production
Schering-Plough has reached an agreement with the US Food and Drug
Administration to correct the firm's manufacturing compliance
problems, which led to a $500 million fine last year.