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.
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...
Drug delivery company Atrix Laboratories confirmed this week that
the German regulatory authority, Bundesinstitut fur Arzneimittel
und Medizinprodukte (BfArM), had recently completed a successful
inspection of Atrix's manufacturing...
EU Commissioner for Research Philippe Busquin underlined the
importance of improving training and information exchange among
scientists on intellectual property (IP) issues at the PATLIB
conference on patent information on 21 May...
European Commission publishes table detailing progress it has made
in negotiating Protocols to the Europe Agreements on Conformity
Assessment and Acceptance of Industrial Products (PECAs) with a
number of accession countries.
The US Food and Drug Administration is gearing up for the first
major overhaul of its current Good Manufacturing Practice
guidelines in 25 years, according to the agency's Commissioner Mark
McClellan. The move is just one strand...
European scientists continue to be strong in areas such as medical
research and chemistry and Europe may produce the highest number of
science graduates but it is lagging behind in biotechnology, still
employs fewer researchers, accounts...
In its first progress report since adopting the EU strategy on life
sciences and biotechnology in 2002, the European Commission
yesterday indicated that the risk of diverging policies in Member
States could seriously hamper the effectiveness...
The US Food and Drug Administration announced this week that it has
accomplished the initial objectives outlined in its ongoing
initiative to modernise the agency's regulation of pharmaceutical
manufacturing and product quality.
UK Shire Pharmaceuticals group said this week that its US
subsidiary Shire Laboratories has filed a lawsuit in the US
District Court against Barr Laboratories for the infringement of
the US patent No. 6,322,819 ( '819 Patent')
AstraZeneca Canada has received approval from the Therapeutic
Products Directorate of Health Canada to market CRESTOR
(rosuvastatin) 10 to 40 mg, a new medicine for the management of
primary high cholesterol (primary hypercholesterolemia),...