The European Association of Pharmaceutical Full-line Wholesalers (GIRP) says it has concerns about the anti-counterfeiting proposals contained in the European Commission's recently-released 'pharmaceutical package.'
The European Union’s coordinated clamp down on counterfeit drugs has resulted in hauls far exceeding expectations, with 34m pills seized in two months.
The European Union’s long-awaited reform of pharmaceutical regulations known as the ‘pharmaceutical package’ was unveiled yesterday after months of consultation and debate.
Icelandic generics firm Actavis plans to use Malta as a distribution hub for the supply of drugs to the emerging African pharmaceutical market, according to reports in the Maltese press.
Competition commissioner Neelie Kroes said that some drugmakers operating in the EU are deliberately stalling the introduction of generics, costing European patients around €3bn ($3.87bn) a year more to buy medicines.
RCP Therapeutics, a developer of regenerative medicine, hopes that its new HQ in the UK will benefit from the country’s status as a financial centre and proximity to cost effective trial sites in Eastern Europe.
The European Parliament has voted in favour of incorporating the United Nations’ (UN) Globally Harmonised System (GHS) for chemical packaging into EU law.
The International Pharmaceutical Excipients Council (IPEC) of Europe has outlined the actions it is taking as it continues to develop awareness of the need for safe excipients.
Despite a decade-long build up, drugmakers are yet to wake up to the “no data, no market” mantra of the EC’s REACH legislation, according to SAFC’s marketing director Amanda Halford.
European technical services and industrial engineering specialist
Imtech says it has received orders worth around €40m ($64m) from
the Belgian operations of firms such as Janssen Pharmaceutica,
GlaxoSmithKline (GSK) and Schering Plough.
European pharmaceutical manufacturers stepped up calls for a
blanket ban on repackaging of pharmaceuticals last week, suggesting
that this would be the single most effective way to seal the supply
chain for counterfeiting drugs.
DSM and the European Chemical Industry Council (CEFIC) have
criticised the European Commission's proposals for tackling
counterfeit active pharmaceutical ingredients (APIs).
The new European Chemicals Agency (ECHA) opened its doors in
Helsinki this week, with questions raised immediately about its
ability to handle the thousands of registration requests required
under the controversial REACH legislation.
The European Union's 2007 pharmaceutical counterfeiting data shows
that almost 40 per cent of fake medicines seized by the EU
originated in Switzerland.
The pharmaceutical industry in the UK faces tougher legislation on
the disclosure of adverse events in clinical trials following the
MHRA's thwarted attempt to prosecute GlaxoSmithKline for allegedly
withholding information about...
The costs of introducing any formal good manufacturing practice
(GMP) requirements for potentially high-risk pharmaceutical
excipients in the European Union would far exceed the likely
benefits, concludes an impact assessment for...
Roche heard early this morning that the European Commission (EC)
has decided to reinstate the marketing authorisation for the
company's HIV drug, Viracept (nelfinavir), but countries outside
the EU have yet to make a final decision.
Two major bioscience industry trade associations have called for
changes to be made to the European clinical trials directive in
order to bring about "harmonisation, transparency and consistency"
in this area across the...
Dutch chemicals and excipients distributor Univar has hooked up
with US manufacturer Innophos to provide the EU pharmaceutical
market with its entire portfolio of excipients, helping to fill the
gap left by the departure of Rhodia...
German firm Biotest has bought up Nabi Biopharmaceuticals biologics
division in a multi-million Euro deal, less than three months after
the unit was created following Nabi restructuring efforts.
J&J has expressed its concern over patient safety as Novartis'
subsidiary Sandoz has received the green light from the European
Commission to launch the first epoetin alfa biosimilar on the EU
market.
'Legislative chaos' has been preventing Poland from reaching its
full potential in the increasingly competitive central Eastern
European (CEE) region, although progress is being made.
Siegfried Generics this week kicked off production at its new
manufacturing facility in Malta making the most of the country's
lack of pharma patents which gives the firm a head-start in
producing generic pharmaceuticals.
Roche has initiated a recall of its HIV drug Viracept (nelfinavir)
right down to the patient level after finding evidence of dangerous
contaminants in the tablets.
The European Commission has released figures showing that there has
been a dramatic and concerning increase in pharmaceutical
counterfeiting, with seizures in Europe hitting an all time high of
over 2.5m items.
Indian biopharmaceutical company Wockhardt Limited has continued
its push into Europe with the all-cash acquisition of France's
Negma Laboratories (Negma-Lerads) for $265m (€195.4m).
An online database detailing information on all manufacturing and
importation certificates and authorisations issued within the
European medicines network has been launched by the European
Medicines Agency (EMEA).
The European Union's (EU) member states must take their
responsibilities to implement the biotech policy proposed by the
European Commission (EC), said EuropaBio, the EU industry body.
The European Parliament has backed proposed legislation to impose
hefty fines and penalties on criminals taking part in piracy and
counterfeiting activities.
Ranbaxy has been granted an EU manufacturing and import license for
its Romania-based Terapia Ranbaxy subsidiary, and says it will make
the company a strategic regional hub for its operations in Europe.
The French Parliament has adopted legislation which prevents
biosimilar medicinal products from being classed as generics and
bans the automatic substitution of one biological medicine for
another.
A new international agreement will eliminate customs duties on
pharmaceuticals and chemical intermediates traded between the major
nations dealing in the industry. The move is set to save EU
pharmaceutical companies around €230m in...
Indian generics company Ranbaxy Laboratories has signed a
development and marketing agreement with generic injectables
company Zenotech Laboratories to produce its first biosimilar, a
granulocyte-colony stimulating factor (G-CSF;...
A group of researchers have come together to form a coalition,
which aims to campaign for the revision directives on the
protection of animals used for scientific research.
Two trade associations of the world's two largest pharma economies
- Europe and the US - took the unusual step of banding together at
the CPhI in Paris to condemn their regulatory authorities for poor
regulation of foreign active...
Environmental representatives have emerged triumphant in the latest
round of negotiations over the finer bones of contention of the
European REACH chemicals legislation, due to come in force in April
next year.
The European Commission continues to be accused by European
industry of pushing 'green policies' that are stifling progress and
global competitiveness - the controversial REACH chemicals
legislation remains a sore point.
The European Union (EU) has been criticised for being more
favourable to big biotech companies, at the expense of smaller
firms, according to consultants within the industry.
European parliamentarians have come up with a long list of measures
that the EU needs to take to combat counterfeit drugs, yet track
and trace technologies were noticeably absent from their calls for
action.
Pharmaceutical manufacturers will be among a number of exporters
and importers operating within the EU that face paying tens of
millions of euros to comply with a new regulation aimed at reducing
terrorism, fraud and counterfeit products.
Copapharm Europe, the alliance of specialist packaging companies,
has announced "healthy" sales figures for 2005, as its
one-stop pan-European approach to the supply of pharmaceutical
packaging equipment is becoming more...
European life sciences received an unexpected boost as the European
Science Foundation launched an initiative to help promote and
coordinate interaction among European life sciences researchers and
funders.
Galvanised by the US, thirteen of the EU's major trading partners
have called for a reconsideration of the EU's draft chemicals
legislation, calling it "potentially disruptive" to world
trade.
