ipq weekly news alert august 23, 2010

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Weekly News Alert August 23, 2010 New Oral Formulation Approaches Are Accelerating Product Movement Into the Clinic The use of micro-dosing in clinical formulations is increasing as firms wrestle with how to get their new oral drug products to the clinic as quickly as possible with the fewest regulatory hurdles…. Increased EMA/Industry Dialogue Needed to Address Upcoming Biopharm Regulatory Challenges, Retiring Quality Director Purves Says The biopharmaceutical regulatory challenges confronting the EMA over the next decade – from biosimilars, advanced therapies, personalized medicine and transgenics to variations and quality by design – will require close industry/regulator dialogue and new communication channels, recently retired EMA Quality of Medicines Head John Purves stressed at CASSS’ European CMC Strategy Forum in Vienna in late May…. Biosimilar Products, Guidelines and Requests for Scientific Advice Continue to Increase in EU The European Medicines Agency (EMA) portfolio of approved biosimilar products and guidelines and the related requests for scientific advice continue to expand, with interest increasing in particular in monoclonal antibodies…. FDA Releases Guideline on Animal Drug Substance CMC Filings in CTD Format FDA’s Center for Veterinary Medicine (CVM) has released a guideline on how to file drug substance CMC information for new and abbreviated new animal drug applications (NADAs/ANADAs) in the Common Technical Document (CTD) format. The CMC guideline was released as a final version rather than as a draft for comment…. EMA Issues Q&A on Supply Chain Traceability to Support Revised Medicinal Gas Annex EMA recently issued a Q&A addressing supply chain traceability expectations for medicinal gases to support the revision to Annex 6 to the EU GMP Guide. The revised annex on “The Manufacture of Medicinal Gases” was adopted by the European Commission at the end of January and became effective at the beginning of August…. www.IPQpubs.com