A simplified way to register complex and innovative raw materials in Europe

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The regulatory environment for registering innovative and complex raw materials differs by region and country. All national health agencies need to ensure that products proposed for their markets are safe, effective and of appropriate quality, so they need sufficient information to make that assessment.

Most national health agencies have a knowledge platform where raw material suppliers can provide information on non-compendial materials – unfortunately, European agencies do not.

This is why BioPhorum has published an Industry proposal for a simplified registration process of complex and innovative raw materials in Europe . This suggests a pragmatic, simple and regulatory-acceptable solution to the challenges around the complex process for registering these raw materials in Europe.

Rachel Thornton, Associate Director at UCB, explained the problems with the current process and how the BioPhorum paper will help to overcome these. “The lack of a clear and consistent process for the communication of proprietary information between suppliers and Health Authorities in Europe has required UCB, and other members to devise complicated workarounds that impact not only the immediate application under review, but all future variations that relate to the same Module 3 section, even if they are unrelated to the raw material in question. Each sponsor has to figure this out independently, which creates inefficiency across the industry. Every minor challenge that we can remove from the process helps us bring new products and product quality improvements to patients more quickly.”

A risk-assessed approach

The paper explores the divergent global regulatory framework for registering these raw materials, and the inconsistent registration process in Europe.

“This article serves as a perfect basis to start discussions with EU agencies about alternative pathways of registration processes for complex raw materials,” said Beatrix Metzner, Head of Global Tech RA at Boehringer Ingelheim. “A scientific and sound registration process will result in smoother and less time-consuming submission activities.”

It is essential to define the attributes of a raw material that are critical to product quality, establish appropriate ranges for those attributes and register these with additional development information. The proposal defines the principles of registration through a risk-assessment approach to development and registration.

This will allow biomanufacturers to ease the pressure on suppliers to share proprietary information for innovative and complex raw materials, replacing this with knowledge-based and scientifically defined critical material attributes and their associated controls.

It will also allow them to enhance the quality of regulatory submissions by demonstrating product and process knowledge and understanding, and potentially improve product and process robustness.

The proposal aligns with ICH principles and includes a case study on a cell culture medium. BioPhorum is not mandating this new approach but offers it as an alternative to the current state. We will monitor regulatory feedback from the European agencies to verify that providing more information about the criticality of raw materials attributes will mean fewer requests by agencies for proprietary information from suppliers.

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