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.
DTI sets up 'good bioanalytical practice' programme
The UK Department of Trade and Industry has commissioned a new
programme, called Measurements for Biotechnology, designed to
develop and share good practice in bioanalytical methodology.
EU hangs back from mandatory EMEA filings
The European Union's Employment, Social Policy, Health and Consumer
Affairs Council agreed on 2 June not to press ahead with proposals
to implement a mandatory centralised marketing authorisation scheme
for all medicines.
Industry group calls for pharma regulation shake-up
The European Federation of Pharmaceutical Industries and
Associations has called for the European Commission to set up a
more favourable legal framework to help the region's pharmaceutical
industry compete with its peers in the...