A consortium of European vaccine experts, including the Swiss CRO Preclin Biosystems, has received almost €5.5m ($7.1m) from the EU to develop a vaccine against the deadly MRSA bacteria.
Chinese oversight of API plants is improving, but it is still important EU importers choose their sources carefully says European Medicines Agency (EMA) collaboration chief, Emer Cooke.
Drugmakers struggling with new EU API import rules now have details of the risk assessments that could solve their problems thanks to the Heads of Medicines Agencies (HMA).
Despite recent progress, the EC underestimated the challenge of getting non-EU regulators to ensure APIs shipped to the European Union (EU) meet new import requirements according to Eucope.
The EMA says new import laws and international collaboration means European drugmakers can now rely on the quality of APIs made outside the European Union.
In an effort to stave off expected drug shortages, the EC has approved a waiver that will allow US API manufacturers to export their products to Europe.
Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association.
Some Chinese firms wont have the 'written confirmations' required to ship APIs to the EU from July according to the German audit firm tasked with helping manufacturers prepare by Beijing industry group, CCCMHPIE.
Epidemiological and other medical research could be prohibitively difficult to conduct if a new European regulation is passed, according to three professors from the University of Amsterdam.
Japan has become the third country outside the EU to be exempt from providing written confirmation that APIs imported into Europe have met required standards when legislation commences on July 2nd.
The EU will become more competitive thanks to new clinical trial regulations that include data transparency, says rapporteur Glenis Willmott MEP, though industry is opposed.
Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
Manufacturing disruptions at Lonza's Hopkinton, Massachusetts site are causing shortages of Ipsen Biopharmaceuticals’ growth failure treatment for children in both the US and EU, just as the company announces that it will shutter another manufacturing...
The EMA’s upgrade to the EudraGMDP database aims to increase the safety of the EU supply chain by releasing GMP certificates and other data so companies can ensure supplier compliance.
Recent changes to EU drug risk-benefit reporting rules mean more work for multinational Pharmas but are still an improvement on ‘old-style’ PSURs says EFPIA.
China and India have more work to do to confirm their API manufacturing sites comply with EU GMP requirements, according to the European Commission’s Pharmaceutical Committee.
The EMA has changed how it monitors the risk-benefit profile of marketed drugs, adopting a single assessment that includes a broader range of API safety reports.
The European CRO Federation is calling to widen the scope of a proposed delegated act related to pharmacovigilance legislation to include scenarios when observational PAES (post-authorisation efficacy studies) will be required.
The UK’s CCRA (Clinical Contract Research Association) says the number of Phase 1 clinical trials in the UK has “decreased substantially” since 2003 and is likely to be further diminished in the next few years.
The EC should add the US and Japan to list of countries exempt from new API import laws and intensify talks with China and India to prevent shortages according to EFPIA.
The European Commission (EC) says timelines for new laws requiring that risky drugs are marked for extra safety monitoring take industry practicalities into account.
Pharmaceutical firms targeting the European market should expect drug review fees to increase by 2.6 per cent from April according to the European Medicines Agency (EMA).
SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.
As many as 300 API manufacturing sites will need to be inspected to prevent drug shortages after new EU import regulations come into effect this summer according to pan-European group the Heads of Medicines Agency (HMA).
US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification.
European API distributors may see costs increase if guidelines requiring quality systems and ‘management representatives’ at distribution points are adopted.
‘Long awaited’ draft guidelines on excipient risk assessments proposed by the European Commission (EC) have been welcomed by industry group IPEC Europe.
An Indian export group has published what it claims are draft CDSCO guidelines setting out what API makers must do to comply with EU import rules that come into effect this summer.
Danish companies that make, use, distribute or import APIs will need to register by March 1 or cease operations according to the Danish Health and Medicines Authority (DKMA).
European drugmakers are seeking between six months and a year to prepare and print updated product information, including the black symbol for drugs that require additional monitoring as part of their approval.
The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.
Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.
The European Union is now recognizing GMP inspections in both Israel and New Zealand, which should lead to less delay in bringing drugs to market and fewer inspections in all three areas.
The European Commission has updated its GMP guidance to notify manufacturing authorization holders (MAHs) of their legal obligation to ensure that active substances are produced in accordance with GMP.
The drug industry is seeking more clarity on the descriptions of variations made to marketed drugs under the European Commission’s regulation governing the ways marketing authorizations can be re-classified.
The UK MHRA says regulators Europe-wide are asking drugmakers for additional data to identify plants that need to be inspected under new EU API import rules.
United Parcel Service (UPS) has abandoned its bid to buy Holland-based logistics firm TNT Express after the European Commission said it would block the deal.
The MHRA says as many as 1,200 active pharmaceutical ingredient (API) manufacturing plants may need to be inspected to secure UK supply chains when new EU import laws come into effect next year.
A European industry group says EU efforts to ensure the quality of API made by manufactureres outside the region are inadequate and that mandatory inspections of overseas plants are a must.
