IPEC e-newsletter - Excipients Insight December 2017 - 18-12-17


Inside this issue


FDA publishes first guidance on 3D-printed pharmaceuticals

The US Food and Drug Administration (FDA) has become the first regulator in the world to issue a technical framework for manufacturers creating medical products on 3D printers.

The new guidance explains the agency’s thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements, and is billed as its “initial thoughts” on the emerging technology, also known as additive manufacturing (AM).

The guidance includes a section (D) on Material controls, and says of starting materials (D.1) such as processing aids, additives, and cross-linkers that they may "undergo significant physical and/or chemical changes" during AM and the specifications for incoming materials and test methods "should be based on the AM technology used ... the intended use of the final medical product, and the information available.

According to FDA Commissioner Scott Gottlieb the new document will “help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”

In an official statement, Gottlieb notes that patients are already benefitting from 3D-printed healthcare products – the first 3D-printed drug (an epilepsy medication) was approved by the FDA back in 2015 – but adds that the FDA “is now preparing for a significant wave of new technologies that are nearly certain to transform medical practice.” More than half a dozen manufacturers have approached the agency to express interest in using 3D printing in some capacity to product medicines.

“We’re working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.”

That shouldn’t require the formulation of additional laws and regulations, he suggested.




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