Diverging Regional Excipient Regulations Are Creating Problems For Excipient Manufacture, Distribution and Use Globally

A review of the way excipients are regulated by agencies around the world reveals that regional regulations continue to proliferate and the differences are creating problems for the manufacture, distribution and use of excipients globally. 

At the 2018 ExcipientFest conference held in San Juan, Puerto Rico at the beginning of May, Biogen Head of Regulatory Intelligence & Pharmacopoeial Affairs Janeen Skutnik-Wilkinson took attendees on a tour of the variegated global excipient regulatory landscape and the challenges it creates for both suppliers and users.

During the presentation, which she titled “Global Excipient Regulations – Multiple Stakeholders, One Objective,” Skutnik-Wilkinson explained how the landscape varies from the lack of regulations in many Latin American countries to the complex regulatory framework that exists in Japan and South Korea.

Her presentation represented an update on the discussions at IPEC-Americas workshops that have taken place at previous ExcipientFests, during which the similarities and differences in the registration/licensing and GMP requirements – as well as both the form and content of what needs to be submitted to support drug applications across the globe – have been reviewed (see IPQ June 17, 2016 and July 1, 2017). The reviews have shown that regulatory agencies differ markedly in the specificity of their requirements for excipients, and whether and how their regulatory processes incorporate registration, master files, specific manufacturing/monograph standards, and approved ingredient lists.

At this year’s ExcipientFest, Skutnik-Wilkinson commented on the lack of consistency and the confusion among industry and regulators on everything from manufacturing licenses, premixed excipients, and atypical actives, to testing requirements, compendial classifications, and use of excipients in parenterals. She highlighted IPEC’s efforts to target and harmonize around best regulatory practices focused on “global patient need.”

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