EU Works Toward More Flexibility, Greater Accountability for APIs

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.