Industry groups have reiterated calls for UK drug approval and safety laws to be kept in line with EU rules, arguing that consistency benefits governments and patients Europe-wide.
Danish regulators have banned Europharma DK ApS from making or importing medicines and drug intermediates after identifying serious breaches of GMP at its plant in Esbjerg.
Aurobindo Pharma Limited has agreed to buy Portugal-based Generis Farmaceutica SA for €135m in a deal that includes a tablet and capsule plant in Amadora.
Italian PM Matteo Renzi has quit after voters rejected his controversial plan for parliamentary reforms, setting the stage for political and economic turmoil.
A plan to attract advanced medicinal therapy manufacturing to the UK has emphasised the importance of the MHRA having a leading role in development of global regulatory standards.
Parexel has launched an Identification of Medicinal Products (IDMP)-focused solution to help biopharmaceutical companies meet impending regulatory requirements.
Development of an EMA and US FDA mutual recognition agreement on drug facility inspections has progressed according to European Commission negotiators who say a deal could be signed by January.
Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO).
The EMA recently appealed two interim orders made by the President of the General Court of the European Union (EU) to suspend the release of clinical trial documents.
European Union API import rules do not ensure ingredients shipped to Europe are of appropriate quality according to APIC board member, Marieke Van Dalen.
Brexit will not stifle interest in the UK’s cell and gene therapy space, says the CGT Catapult which has reported a tenfold growth in investment since 2012 to £400m ($520m).
More than two months after Britain decided to leave the EU, companies reevaluate the state of business and what comes next, specifically for jobs within the industry.
An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.
Jinan Jinda Pharmaceutical Chemi has not fixed GMP deficiencies at its Shandong plant say Spanish regulators calling for ban on nitrofurantoin shipments to the EU.
The EMA is recommending the suspension of several medicines after inspections revealed flawed studies at the India-based contract research organization (CRO), Semler Research Centre.
The Council of the EU has unveiled a plan to analyse the competitive landscape for pharmaceuticals in Europe in a bid to improve patients' access to medicines.
Brexit: Indian firms worried but Big Pharma and EMA remain positive for now
The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.
The UK biosimilars industry has urged the Government to push for a single marketing authorisation in its upcoming negotiations with the EU, following today’s shock Brexit result.
CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.
Organisations that identify API manufacturers whose manufacturing activities spread antimicrobial resistance will be considered alongisde other NGOs for a new European Commission award.
CMC Biologics as upped its production capacity at its Copenhagen facility with plans to have equivalent capacity on both sides of the Atlantic in 2017.
Roche’s subcutaneous formulation of MabThera is about reducing the treatment burden for patients and not protecting it from impending biosimilar competition, the firm says.
ClinTec International has opened two new offices in Spain as it prepares for an expanding local clinical trial portfolio and larger outsourcing engagements in the country.
Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).
Exco InTouch has formed a strategic partnership with Regulatory Strategies, a data protection and compliance consultancy, in response to upcoming reforms.
Big Pharma has returned to Europe for its API sourcing due to reasons of quality and reliability, according to the European Fine Chemicals Group (EFCG).
Illegal internet pharmacies and a desire for cheaper meds mean fake drugs are a problem even in smaller pharmaceutical markets say Estonian regulators.
