Regulators in Non-EU countries can use results of previous inspections of API plants by EU or equivalent authorities in written confirmations, according to the European Commission.
Outsourcing-Pharma.com presents its weekly round-up of the latest changes, faces and places in the pharma services sector, including news from Wolters, Advanced Clinical and BIA.
Stricter GMP requirements in Peru are increasing the time it takes to get drugs approved and may not be giving regulators any useful additional information.
Proposed EMA pharmacovigilance fees are too high and place a disproportionate burden on generics firms according to the European Generic Medicines Association (EGA).
The proposed changes to European clinical trial regulations accepted by the European Commission (EC) in July will put Europe on an equal playing field, according to Clinipace’s Andrea Schiefer.
Parexel says EU trials directive never achieved harmonization aims and welcomes plans to simplify regulations, even if the implementation date is further away than expected.
Unilife has been granted a US patent for its prefilled syringe technology just weeks after announcing a supply contract with an unnamed autoimmune disease-focused pharma.
So far only Switzerland and Israel have asked to be included in the list of countries not required to provide written confirmation that plants making APIs destined for the EU meet the required standards according to an EC statement.
European laws on clinical trials need to be faster and more efficient but they are not the only reason for the decline in the sector according to EU health and consumer policy commissioner John Dalli.
Indian API manufacturers may dominate the list of companies that have had CEPs suspended this year, but that may say more about inspection policies than it does about standards outside Europe.
Quintiles has inked a deal with Delcath which will see it deploy a team of medical experts to support the European launch of the Hepatic Chemosat Delivery system.
The joint US FDA and EMA active pharmaceutical ingredient (API) manufacturing facility inspection programme has signed up the World Health Organisation as a member.
Regulation over combination products must be simplified to get products to market quicker, said Marielle Fournier, director of Voisin Life Sciences Consulting.
Draft EU GDP guidelines would “significantly increase” supply-chain costs and be “virtually impossible” to carry out, big pharma and logistics companies said.
The Council of Europe (CoE) has launched an online service which will allow patients to check the authenticity of their medication using just a smartphone.
BASF has hiked its prices for ethanolamines just days after asking the European Commission to review measures designed to stop US exporters selling the compound to manufacturers in Europe at less than cost.
State-border delays, tolls and paperwork are increasing logistics costs in India and making transit less efficient than the EU and China, a report found.
The glass packaging industry in Europe posted a 3.5 per cent year-on year production increase to 20.7m tonnes in 2010 as output partially recovered from its 2009 slump.
Brussels should step in to break the decade-long deadlock over the setting up of a mandatory registry for nanomaterial-containing products, said the European Trade Union Institute (ETUI).
The European Union (EU) formally adopted the falsified medicines directive at the weekend, giving member states 18 months to makes the document's anti-counterfeiting track and trace measures into national law.
Outsourcing-Pharma presents its latest round up of movements in the pharma outsourcing sector, including appointments at Icon, Quintiles, Catalent and CRF Health.
Non-clinical CRO CIT will distribute Stemina’s hES-based toxicity testing platform to pharmaceutical and cosmetics developers in Europe under an agreement announced late last week.
