More flexibility, greater accountability for APIs expected in Europe with new guidelines on the European Union's variations regulation and an anti-counterfeiting legislative proposal, say speakers at APIC/CEFIC meeting in Paris. The European Parliament has agreed with a European Commission proposal to require communitywide alignment of member state variations requirements, and to allow more types of manufacturing changes to proceed without prior approval. However, EU API makers have some concerns. Quality by design for APIs discussed. European Commission proposes counterfeit directive requiring tracking features, audits of API manufacturers and posting of inspection results. Tips shared for auditing API suppliers and traders.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.
Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.
Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.
