Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in planned European Commission reshuffle.
The EU commission plans to strip DG Sanco of responsibility for the running the European Medicines Agency (EMA) and hand it to the directorate in charge of enterprise and industry.
Brussels airport has become the first European shipping hub to adopt a cold-chain certification programme for pharmaceutical cargo that industry group IATA claims “goes beyond” GDP requirements.
Italian health Minister Beatrice Lorenzin will focus on making drug National price regulations and decisions more trasnparent during the country's presidency of the EU.
The UK Government should seek licenses to use off-patent drugs in new indications according to MPs who say there is no incentive for pharma firms to apply for such approvals after a product goes generic.
As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency.
Germany-based full-service CRO (contract research organization) Accovion has expanded European presence with new offices in Italy, France and Eastern Europe.
Basic pharmaceuticals including APIs became even more important revenue generators for Ireland in 2013 according to new data released by the Central Statistics Office (CSO).
The Management Board of the EMA (European Medicines Agency) has postponed the formal adoption of its policy on publication of clinical trial data, though the agency stopped short of revealing exactly why.
In a sweeping report on the industry as a whole, the European Commission says that with an annual output of €220bn, and nearly 800,000 employees, the pharma industry is vital for the EU economy, though more needs to be done to meet its full potential.
A European expert has cast doubt on a claim by Indian regulator CDSCO that it can assess and confirm the quality of an API supplier’s manufacturing operations in writing in just 30 days.
The EMA is being criticised on two fronts with some suggesting its trial data publication plans will drive away drug R&D while others argue the agency is backtracking in a way that will hinder public health research.
The European Commission (EC) can order the withdrawal of medicines that are not produced in accordance with GMP without having to prove they pose a specific health risk after a ruling in the EU Court of Justice.
European regulatory authorities have reinstated the Good Manufacturing Practice (GMP) certificate at Ranbaxy Laboratories’ API manufacturing site in Toansa, India, which was suspended in January.
European pharmaceutical manufacturing jobs are at risk according to a group representing generic firms which says price caps in EU member states are hurting drugmakers.
In a letter to the EMA (European Medicines Agency), the European Ombudsman Emily O'Reilly has expressed concern that a significant change of policy on trial data transparency could limit the amount of data that becomes available.
The European Medicines Agency (EMA) has published guidance for departing employees intended to ensure there is no conflict of interest in their new roles.
The British Generic Manufacturers Association (BGMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a forum for the generics industry to discuss manufacturing and quality issues.
Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.
The EMA (European Medicines Agency) has cut what it charges small and medium-sized enterprises (SMEs) and micro businesses to help them comply with regulations once their drugs are approved.
Pharmaceutical companies will be made to publish all European clinical trials in a public database under a draft law passed by the European Parliament yesterday.
Collating drug counterfeiting cases from across Europe into a central database will help law enforcement authorities catch criminals trying to flood the region with fake medicines, according to the EDQM.
Plans to give customs officers the power to seize and destroy suspected fake medicines as they move through the EU have been welcomed by industry group EFPIA.
The European Commission (EC) has increased the pressure on Ireland, Italy, Poland and Slovenia to fall into line with other EU member States and introduce anti-drug counterfeiting legislation.
European dependence on drugs and APIs made outside the EU is still ‘alarming’ despite recently introduced anti-falsified meds laws according to the European Fine Chemicals Group (EFCG).
Drugmakers and academics will have to upload the results of trials run in Europe to a public database under a provisional deal agreed in the European Parliament earlier today.
Fewer animals were used to test the safety of life saving drugs in Europe in 2011 than in previous years according to the sixth edition of a research report by the European Commission last week.
Asking qualified persons (QP) to certify that drug batches comply with manufacturing quality rules in destination EEA markets is unrealistic say groups commenting on proposed revisions to Annex 16 of the EU GMP guidelines.
The high cost of energy in the UK is having a negative impact on drug and chemical firms' ability to compete according to manufacturers quizzed by the Chemical Industries Association (CIA).
Concerns recently introduced import laws would cause EU-wide API shortages now appear unfounded, but European industry groups say the buffering effects of stockpiling mean it is still too early to be sure supplies will not be affected.
Ben Venue’s closure is still being evaluated the troubled drugmaker says, in the week the European Medicines Agency (EMA) is meeting to discuss ongoing shortages.
Teva subsidiary Pliva has opened a new $100m (€73m) oral dosage manufacturing facility in Zagreb, Croatia to increase its export of tablets and capsules to the US and EU.
CRO Harlan Laboratories, has expanded its specialty research production facility in southern Europe to provide its complete portfolio of contract breeding and health monitoring services to clients in Europe.
CROs have an important role to play in reducing the number of animals used in drug development and – potentially – much to gain by doing so, according to the European Commission.
